FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIEWCATH 3-D CATHETER PULLBACK
K Number: K971397
·
Decision Aug 25, 1997
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
164
Review Days
132
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Basic Information
- Device Name
- VIEWCATH 3-D CATHETER PULLBACK
- K Number
- K971397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quinton, Inc.
- Date Received
- April 15, 1997
- Decision Date
- August 25, 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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|---|---|---|---|
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| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Mar 6, 2000 | Substantially Equivalent |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Apr 29, 1999 | Substantially Equivalent |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | Aug 13, 1997 | Substantially Equivalent |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | Sep 13, 1996 | Substantially Equivalent |
| K961014 | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | Jul 31, 1996 | Substantially Equivalent |