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BMC COAXIAL INJECTABLE CATHETER - Cic 35

by Baylis Medical Co., Inc.

510(k) K014075

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 NumberK014075 Date7 Mar 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0356-2016 FDA Class II initiated 28 Oct 2015

    Microcatheter may have circumferential defects (cracks) along its shaft.

    • Terminated Z-1442-2015 FDA Class II initiated 30 Mar 2015

    Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

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  • Withdrawn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
DQX
Models / Variants
Cic 35
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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