510(k) K090547 ยท NEU Marker, Radiographic, Implantable
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Mar 18, 2009 |
| Received | Mar 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2013 | Bard Peripheral Vascular Inc BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic Terminated |
NEU | None listed |
| Jun 10, 2013 | Bard Peripheral Vascular Inc BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, N Terminated |
NEU | None listed |
| Jun 10, 2013 | Bard Peripheral Vascular Inc MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc Terminated |
DQY | None listed |
| Jun 10, 2013 | Bard Peripheral Vascular Inc USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 N Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.