Cardiovascular Diagnostics, Inc.
Morrisville, NC, US
Cardiovascular Diagnostics, Inc. appears in FDA device records in Morrisville, NC. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Cardiovascular Diagnostics, Inc. between 1995 and 2002. The busiest year on record is 1996, with 4. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013305 | ENOXAPARIN TEST CARD | KFF | Substantially Equivalent | |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | JBP | Substantially Equivalent | |
| K994159 | HMP CONTROLS (TAS) RAPIDPOINT | GGN | Substantially Equivalent | |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | JOX | Substantially Equivalent | |
| K990566 | TAS ANALYZER, MODEL 1009 | JPA | Substantially Equivalent | |
| K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | GKP | Substantially Equivalent | |
| K981178 | THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS | GGN | Substantially Equivalent | |
| K971748 | TAS PT-NCTEST CONTROLS | GGN | Substantially Equivalent | |
| K961814 | THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS | GIZ | Substantially Equivalent | |
| K961189 | TAS A PTT TEST CONTROLS | GGN | Substantially Equivalent | |
| K960234 | TAS HMT CONTROLS | GGN | Substantially Equivalent | |
| K954625 | PROTHROMBIN TIME TEST CARD | GJS | Substantially Equivalent | |
| K943283 | HEPARIN MANAGEMENT TEST CARD; HMT CARD | KFF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain