510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130382Substantially Equivalent

Heartstring III Proximal Seal System

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

K130382 is the FDA 510(k) clearance record for HEARTSTRING III PROXIMAL SEAL SYSTEM, a class II device, cleared for Boston Scientific Corporation 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 3 recalls naming K130382.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation 45 Barbour Pond Dr., Wayne NJ
510(k) summary
Summary PDF
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