CVD BULLET INFUSION CATYHETER— 510(k) K951502
Substantially EquivalentCardiovascular Dynamics, Inc.
FDA 510(k) clearance K951502 for CVD BULLET INFUSION CATYHETER, Substantially Equivalent on 1995-05-10. Applicant: Cardiovascular Dynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Dynamics, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KRA
view allMore clearances from Cardiovascular Dynamics, Inc.
view all- K973713 — 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
- K971577 — FOCUS-PV BALLOON DILATATION CATHETER
- K963989 — P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
- K963688 — FOCUS PV BALLOON DILATATION CATHETER
- K945693 — CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER
Adverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.