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FieldFlex Sheath FXS-MD-001599

by CenterPoint Systems LLC

FieldFlex Sheath FXS-MD-001599 is a vascular guide-catheter (FDA Class II; FDA product code DYB, Introducer, Catheter) made by CenterPoint Systems LLC, cleared under FDA 510(k) K261492 on 5 Jun 2026 and listed in FDA GUDID since 23 Oct 2026 (UDI-DI 00810024673131), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K261492

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810024673131 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK261492 Date5 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261492 decided 5 Jun 2026 Active
  • FDA GUDID UDI-DI 00810024673131 listed 23 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261492
  2. Listed FDA GUDID 00810024673131

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FieldFlex Sheath
Generic name
Vascular guide-catheter, single-use
Model / reference
FXS-MD-001599
Primary DI / UDI-DI
00810024673131
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 (K261492)

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

Other devices from CenterPoint Systems LLC

See all devices from CenterPoint Systems LLC →

Properties

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