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Heartport Endocoronary Sinus Cathetr

by Heartport, Inc.

510(k) K964248

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964248 Date22 Jan 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2776-2011 FDA Unclassified (pre-2012) initiated 15 Jun 2011

    Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.

    • Terminated Z-0991-2011 FDA Unclassified (pre-2012) initiated 3 Dec 2010

    Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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