510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080169Substantially Equivalent

Heartstring III Proximal Seal System

Guidant Corporation, Cardiac Surgery, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080169 is the FDA 510(k) clearance record for HEARTSTRING III PROXIMAL SEAL SYSTEM, a class II device, cleared for Guidant Corporation, Cardiac Surgery on under FDA product code DXC (Clamp, Vascular). FDA records list 8 510(k) clearances for Guidant Corporation, Cardiac Surgery, from to . As of , FDA records show no recalls naming K080169.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corporation, Cardiac Surgery 170 Baytech Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
Yes

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