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DiRex™ Steerable Sheath M004DSD100

by Oscor Inc.

DiRex™ Steerable Sheath M004DSD100 is a Class II device made by Oscor Inc., cleared under FDA 510(k) K120459 on 29 Jun 2012 and listed in FDA GUDID since 31 Mar 2026 (UDI-DI 00885672013080), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K120459

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885672013080 UDI-DI Date31 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120459 Date29 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120459 decided 29 Jun 2012 Active
  • FDA GUDID UDI-DI 00885672013080 listed 31 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120459
  2. Listed FDA GUDID 00885672013080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DiRex™ Steerable Sheath
Generic name
Vascular guide-catheter, single-use
Model / Ref / Catalog
M004DSD100
Primary DI / UDI-DI
00885672013080
510(k) Number
FDA product code
DYB
GMDN term
Vascular guide-catheter, single-use
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K120459)

and 8 more cleared under K120459

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)