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Electrode Recording Catheter

by Boston Scientific

510(k) K954651

Electrode Recording Catheter is a Class II device made by Boston Scientific, cleared under FDA 510(k) K954651 on 22 Oct 1996, 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 · Traditional NumberK954651 Date22 Oct 1996ClearedStatusActive

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  • Withdrawn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
DRF
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1220
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording).

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