510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955132Substantially Equivalent

Heartport Endoaortic Clamp

Heartport, Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955132 is the FDA 510(k) clearance record for HEARTPORT ENDOAORTIC CLAMP, a class II device, cleared for Heartport, Inc. on under FDA product code DXC (Clamp, Vascular). FDA records list 24 510(k) clearances for Heartport, Inc., from to . As of , FDA records show 2 recalls naming K955132.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Heartport, Inc. 200 Chesapeake Dr., Redwood City CA
510(k) summary
Summary
Third party review
No

Clearances, product code DXC

Trailing 12 months
6 clearances under product code DXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20261
August 20260
September 20260
October 20260