510(k) K052036 ยท DQY Catheter, Percutaneous
ATB ADVANCE PTA DILATATION CATHETER
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 25, 2005 |
| Received | Jul 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2007 | Cook, Inc. Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.