GUARDIAN II NC HEMOSTASIS VALVE— 510(k) K101113
Substantially EquivalentZerusa Limited
FDA 510(k) clearance K101113 for GUARDIAN II NC HEMOSTASIS VALVE, Substantially Equivalent on 2010-05-21. Applicant: Zerusa Limited. Device class: 2.
Clearance details
- Applicant
- Zerusa Limited
- Product code
- Code DTL
- Device class
- Class 2
- Regulation
- 21 CFR 870.4290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code DTL
view allMore clearances from Zerusa Limited
view allAdverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K101113
K-number listed on FDA's recall record- 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.
- Z-2400-2012 — Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101113.
Data sourced from openFDA. This site is unofficial and independent of the FDA.