510(k) K992347 ยท DQO Catheter, Intravascular, Diagnostic
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
| Applicant | Cordis Corp., Warren NJ, US |
| Decision | Substantially Equivalent, Oct 8, 1999 |
| Received | Jul 14, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2021 | Cordis Corporation Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB Terminated |
DQO | None listed |
| Sep 15, 2021 | Cordis Corporation Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB Terminated |
DQO | None listed |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A Terminated |
DQO | None listed |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B Terminated |
DQO | None listed |
| Sep 15, 2021 | Cordis Corporation Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C Terminated |
DQO | None listed |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter** Terminated |
DQO | None listed |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sidehole Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.