510(k) K811378 ยท GBW Catheter, Peritoneal
PERCUTANEOUS DRAINING CATHETER
| Applicant | Medi-Tech, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 2, 1981 |
| Received | May 15, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2017 | Boston Scientific Corporation Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980
The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collectin Terminated |
GBW | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001205501 SACKS SS/6FR/28CM (BX/5)
M001205 Terminated |
GBW | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001221000 AA/8/30
M001221010 AA/10/30
M001 Terminated |
FGE | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001201050 VSKCL-12
M001201060 VSKCL-14
M00 Terminated |
FGE | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001245260 VTCG/8/25
M001245270 VTCG/10/25
Terminated |
FGE | None listed |
| Sep 13, 2006 | Boston Scientific Corp Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201. Terminated |
GBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.