Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra System Reperfusion Catheter JET 7

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo® Aspiration System - Lightning® Flash

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Benchmark BMX96 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Benchmark BMX96 Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo Aspiration System - Lightning Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA EMBOLIZATION COIL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra System, Penumbra Pump MAX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Indigo® Aspiration System – Aspiration Catheter 6X

FDA 510(k)

FDA Class 2 ·Cardiovascular

Access25™ Delivery Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Penumbra System (Reperfusion Catheter RED 62)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA ASPIRATION PUMP, MODEL 115V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Penumbra System 3D Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA SYSTEM MAX

FDA 510(k)

FDA Class 2 ·Cardiovascular