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Occlusion Catheter

by Bionomy, Inc.

510(k) K811276

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK811276 Date30 Jun 1981ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1751-2025 FDA Class II initiated 11 Apr 2025

    During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

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  • Withdrawn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
DYG
Device Class
Class II
Regulation
21 CFR Part 870.1240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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