Company ยท US
Cardiovascular Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2002. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2002 | K013305 | ENOXAPARIN TEST CARD Cardiovascular Diagnostics, Inc. | KFF |
| Mar 28, 2000 | K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT Cardiovascular Diagnostics, Inc. | JBP |
| Feb 15, 2000 | K994159 | HMP CONTROLS (TAS) RAPIDPOINT Cardiovascular Diagnostics, Inc. | GGN |
| Jan 14, 2000 | K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST Cardiovascular Diagnostics, Inc. | JOX |
| May 14, 1999 | K990566 | TAS ANALYZER, MODEL 1009 Cardiovascular Diagnostics, Inc. | JPA |
| May 26, 1998 | K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) Cardiovascular Diagnostics, Inc. | GKP |
| Apr 27, 1998 | K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| May 29, 1997 | K971748 | TAS PT-NCTEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| Aug 13, 1996 | K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS Cardiovascular Diagnostics, Inc. | GIZ |
| Jun 5, 1996 | K961189 | TAS A PTT TEST CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| May 30, 1996 | K960234 | TAS HMT CONTROLS Cardiovascular Diagnostics, Inc. | GGN |
| Mar 11, 1996 | K954625 | PROTHROMBIN TIME TEST CARD Cardiovascular Diagnostics, Inc. | GJS |
| May 10, 1995 | K943283 | HEPARIN MANAGEMENT TEST CARD; HMT CARD Cardiovascular Diagnostics, Inc. | KFF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||