GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE— 510(k) K122301

Clearance details

Applicant

Vascular Solutions Zerusa , Ltd.

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

2012-08-01

Decision date

2012-09-07

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

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 →

• Z-1275-2016 — Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.Class I·Terminated·Vascular Solutions, Inc.·20160304
• Z-0955-2013 — Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.Class I·Terminated·Vascular Solutions, Inc.·20130227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122301.