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Torflex Transseptal Guiding Sheath

by Baylis Medical Co., Inc.

510(k) K013919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013919 Date22 Feb 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0816-2010 FDA Unclassified (pre-2012) initiated 8 Feb 2010 on shared 510(k) K013919

    Radiopaque soft tip may fracture.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DBY
Device Class
Class I
Regulation
21 CFR Part 866.5520
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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