510(k) K810368 ยท KOB Catheter, Suprapubic (And Accessories)
VANCE PERCUTANEOUS MALECOT NEPHROSTOMY
| Applicant | Vance Products, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Mar 20, 1981 |
| Received | Feb 12, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2019 | Cook Inc. Cook Salle Intraoperative Pyeloplasty Stent Set
PRODUCT/CATALOG NUMBER/GPN:
4.0 Fr - SIPSF-040018-56-6 G18168
4.0 Fr - SIPSF-040018-59 G32773
4.7 Fr SIPSF-050018-59 G32774 Terminated |
KOB | None listed |
| Jan 4, 2019 | Cook Inc. Percutaneous Malecot Nephrostomy Set, Global Product No. G16714
G19107
G19108 Terminated |
KOB | None listed |
| Jan 4, 2019 | Cook Inc. Percutaneous Pigtail Nephrostomy Set
, Global Product No. G14094
G14095
G14899
G14329 Terminated |
KOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.