510(k) K141322 ยท PNO Catheter, Percutaneous, Cutting/Scoring
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 27, 2015 |
| Received | May 20, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is i Terminated |
PNO | None listed |
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is i Terminated |
PNO | None listed |
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is Terminated |
PNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.