510(k) K853370 ยท GYK Instrument, Shunt System Implantation
H-H CATHETER PASSERS(TACL DESIGN
| Applicant | Holter-Hausner Intl., Bridgeport PA, US |
| Decision | Substantially Equivalent, Sep 18, 1985 |
| Received | Aug 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2003 | Vygon US LLC Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle. Terminated |
FOZ | None listed |
| Nov 27, 2003 | Vygon US LLC Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle. Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.