Penumbra Inc.

Lot number F15020

Neurological Devices

2

No

Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.

Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.

Lot numbers F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, and F14629.

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.

Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. || Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

F17211, F17212, F17213, F17214, F17215, F17216, F17256, F17257, F17258, F17259, F17260, F17310, F17311, F17333, F17334, F17335, F17336, F17337, F17338, F17339, F17340, F17374, F17375, F17376, F17395, F17396, F17397, F17398, F17399, F17400, F17401, F17402, F17403, F17404, F17405, F17440, F17441, F17442, F17443, F17444, F17445, F17446, F17447, F17448, F17485, F17486, F17487, F17489, F17507, F17511, F17512, F17513, F17514, F17515, F17516, F17517, F17564, F17565, F17566, F17567, F17568, F17569, F17668, F17669, F17670, F17672, F17673, F17675, F17676, F17705, F17706, F17707, F17708, F17710, F17735, F17736, F17737, F17738, F17739, F17740, F17741, F17742, F17743, F17744, F17745, F17780, F17781, F17782, F17783, F17790, F17791, F17792, F17793, F17794, F17833, F17834, F17835, F17836, F17837, F17838, F17839, F17840, F17841, F17842, F17843, F17844, F17900, F17901, F17902, F17903, F17904, F17905, F17906, F17907, F17908, F17924, F17925, F17926, F17927, F17928 , F17929, F17930, F17931, F17932, F17933, F17934, F17935, F17936, F17966, F17967, F17968, F17969, F17970, F17971, F17972, F17973, F17974, F17975, F17976, F17977, F17999, F18000, F18001, F18002, F18021, F18022, F18023, F18024, F18041, F18042, F18043, F18044, F18045, F18046, F18047, F18066, F18068, F18073, F18074, F18075, F18076, F18090, F18091, F18092, F18093, F18094, F18121, F18122, F18123, F18124, F18125, F18126, F18127, F18128, F18129, F18146, F18147, F18148, F18149, F18150, F18151, F18152, F18153, F18179, F18180, F18181, F18182, F18183, F18184, F18185, F18186, F18194, F18195, F18196, F18197, F18231, F18232, F18233, F18234, F18235, F18236, F18239, F18240, F18241, F18242, F18243, F18244, F18245, F18246, F18247, F18248, F18249, F18291, F18292, F18293, F18294, F18295, F18307, F18308, F18309, F18336, F18337, F18338, F18373, F18374, F18375, F18387, F18388, F18389, F18400, F18401, F18415, F18416, F18417, F18449, F18450, F18451, F18457, F18458, F18459, F18460, F18461, F18479, F18480, F18481, F18482, F18483, F18484, F18485, F18486, F18487, F18488, F18513, F18514, F18515, F18516, F18517, F18518, F18519, F18520, F18521, F18550, F18551, F18552, F18553

Neurological Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.

Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA || The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Microcatheter.

Catalog number PND6F11512M, lot number F14751

Cardiovascular Devices

2

No

CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.

Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA || Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

Catalog Number: PNS5f130H1; Lot Number: F15174.

Cardiovascular Devices

2

No

Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.

Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. || Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.