Skip to content

FASTLOCK - PC175M01

by European Custom Manufacturing BV 510(k)

Active United States

510(k) K080621

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080621 Date29 Apr 2008ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSA
Models / Variants
PC175M01
Device Class
Class II
Regulation
21 CFR Part 870.2900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from European Custom Manufacturing BV