FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
K Number: K963989
·
Decision Apr 24, 1997
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
11
Review Days
202
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Basic Information
- Device Name
- P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
- K Number
- K963989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiovascular Dynamics, Inc.
- Date Received
- October 4, 1996
- Decision Date
- April 24, 1997
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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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 |
| 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 |
| K944016 | FOCUS BALLOON DILATATION CATHETER | Dec 20, 1994 | 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 |