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FieldFlex Steerable Sheath

by CenterPoint Systems LLC

510(k) K261492

FieldFlex Steerable Sheath is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by CenterPoint Systems LLC, cleared under FDA 510(k) K261492 on 5 Jun 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK261492 Date5 Jun 2026ClearedStatusActive

Official records

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  • Withdrawn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
DYB
FDA applicant
CenterPoint Systems, LLC
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K261492

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K261492
UDI-DISize and differences
FieldFlex Sheath FXS-MD-001599
CenterPoint Systems LLC
FXS-MD-00159900810024673131 —On the market
FieldFlex Sheath FXS-MD-002000
CenterPoint Systems LLC
FXS-MD-00200000810024673148 —On the market

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 →