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Dilation Catheter, Balloon

by Boston Scientific

510(k) K965067

Dilation Catheter, Balloon is a Class II device made by Boston Scientific, cleared under FDA 510(k) K965067 on 28 Jan 1997, 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 NumberK965067 Date28 Jan 1997ClearedStatusActive

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  • Withdrawn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
GBM
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 876.5130
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code GBM (Catheter, Urethral).

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