510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203440Substantially Equivalent

Penumbra System (Reperfusion Catheter RED 62)

Penumbra Inc., Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203440 is the FDA 510(k) clearance record for Penumbra System (Reperfusion Catheter RED 62), a class II device, cleared for Penumbra, Inc. on under FDA product code NRY (Catheter, Thrombus Retriever). FDA's definition for product code NRY reads: "The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary...". FDA records list 87 510(k) clearances for Penumbra, Inc., from to . As of , FDA records show no recalls naming K203440.

Clearance record

Decision date
Received
(178 days to decision)
Product code
NRY Catheter, Thrombus Retriever
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Penumbra, Inc. One Penumbra Pl., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRY

Trailing 12 months
13 clearances under product code NRY in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code NRY, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20262
April 20260
May 20262
June 20261
July 20261
August 20264
September 20261
October 20260