FOCUS BALLOON DILATATION CATHETER— 510(k) K944016
Substantially EquivalentCardiovascular Dynamics, Inc.
FDA 510(k) clearance K944016 for FOCUS BALLOON DILATATION CATHETER, Substantially Equivalent on 1994-12-20. Applicant: Cardiovascular Dynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Dynamics, Inc.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code LIT
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 LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.