FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOCUS BALLOON DILATATION CATHETER
K Number: K944016
·
Decision Dec 20, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
11
Review Days
126
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Basic Information
- Device Name
- FOCUS BALLOON DILATATION CATHETER
- K Number
- K944016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiovascular Dynamics, Inc.
- Date Received
- August 16, 1994
- Decision Date
- December 20, 1994
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiovascular Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973713 | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | Jan 23, 1998 | Substantially Equivalent |
| K971577 | FOCUS-PV BALLOON DILATATION CATHETER | Jun 18, 1997 | Substantially Equivalent |
| K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | Apr 24, 1997 | Substantially Equivalent |
| K963688 | FOCUS PV BALLOON DILATATION CATHETER | Mar 28, 1997 | Substantially Equivalent |
| K945693 | CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952064 | FOCUS BALLOON DILATATION CATHETER | Jun 21, 1995 | Substantially Equivalent |
| K951502 | CVD BULLET INFUSION CATYHETER | May 10, 1995 | Substantially Equivalent |
| K951503 | CVD BULLETT HI-FLO INFUSION CATHETER | May 4, 1995 | Substantially Equivalent |
| K945465 | CVD SMALL VESSEL BALLOON DILATATION CATHETER | Dec 20, 1994 | Substantially Equivalent |
| K943023 | CVD BULLETT PERIPHERAL INFUSION CATHETER | Sep 30, 1994 | Substantially Equivalent |