510(k) K832287 ยท DYG Catheter, Flow Directed
NOVA BALLOON THERMODILUTION INFUSION
| Applicant | Nova Medical Specialties, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 19, 1983 |
| Received | Jul 13, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | B. Braun Medical, Inc. Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601129-----5011094 0106 x 1007BBMWS. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601258----WP604P Wedge Press Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601261-----WP605P Wedge Press Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601272------WP1106 Wedge Press Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601276 ----WP1107 Wedge Press Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601285-----WP11055 Wedge Press Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 601293------------WP1107S Monitory Wedge Press. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604000------417D1006I. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604025------------T046-02 0426D1009I RMM. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604028------------T047(90) 427D1022I. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604037------T047-02 0427D10061. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604057---------------T147 A427D1014KANI Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604103-------------T047(97) 427D4036I. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604165-------------T047-04 0427D1022I. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604239-------------426D1009I. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604264-------------427D1006I Round Molded Manifold. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 604315-------------406-1H-018 426D1009I18PP. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 608054------------827D1006I 4P BBM RMM Cath. Terminated |
DYG | None listed |
| Jul 16, 2005 | B. Braun Medical, Inc. Right Heart Catheter Product Line:
Catalog Number 608055-------------827D1006I 4P BBM RMM Cath. Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.