510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022880Substantially Equivalent

Guidant Proximal Seal System, Models Pss-4500 & Ps-4500

Boston Scientific Corporation, Lafayette CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022880 is the FDA 510(k) clearance record for GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500, a class II device, cleared for Guidant Corp. on under FDA product code DXC (Clamp, Vascular). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K022880.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corp. 3744 Mt. Diablo Blvd., Lafayette 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