Cardiovascular Dynamics, Inc.
Irvine, CA, US
Cardiovascular Dynamics, Inc. appears in FDA device records in Irvine, CA. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Cardiovascular Dynamics, Inc. between 1994 and 1998. The busiest year on record is 1995, with 4. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 4 |
| 1997 | 3 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973713 | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | ITX | Substantially Equivalent | |
| K971577 | FOCUS-PV BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | ITX | Substantially Equivalent | |
| K963688 | FOCUS PV BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K945693 | CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K952064 | FOCUS BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K951502 | CVD BULLET INFUSION CATYHETER | KRA | Substantially Equivalent | |
| K951503 | CVD BULLETT HI-FLO INFUSION CATHETER | KRA | Substantially Equivalent | |
| K945465 | CVD SMALL VESSEL BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K944016 | FOCUS BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K943023 | CVD BULLETT PERIPHERAL INFUSION CATHETER | FOZ | 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