GATOR CLIPSEAL PLUG— 510(k) K092563

Clearance details

Applicant

Vascular Solutions, Inc.

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

2009-08-20

Decision date

2009-11-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

• K152528 — Attachable Cath Lab Hemostasis Valve2015-12-02
• K143429 — Passage Hemostasis Valve2014-12-22
• K140475 — ROTATING ADAPTERS2014-04-16
• K131124 — COLIGN2013-08-28
• K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE2012-12-13

• K182232 — Octane Mechanical Thrombectomy System2018-09-11
• K181647 — Bandit guidewire2018-07-20
• K180913 — VSI Micro-Introducer Kit2018-05-09
• K180088 — TrapLiner catheter2018-04-04
• K180128 — Warrior 14 guidewire2018-02-16

Malfunction

770

Total

770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →