FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
K Number: K982883
·
Decision Sep 4, 1998
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
21
Review Days
18
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Basic Information
- Device Name
- MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
- K Number
- K982883
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronics Interventional Vascular
- Date Received
- August 17, 1998
- Decision Date
- September 4, 1998
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Medtronics Interventional Vascular
| K Number | Device Name | ||
|---|---|---|---|
| K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS | Mar 22, 1999 | Substantially Equivalent |
| K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER | Dec 10, 1998 | Substantially Equivalent |
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER | Aug 7, 1998 | Substantially Equivalent |
| K972944 | MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT | Nov 3, 1997 | Substantially Equivalent |
| K961917 | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) | Nov 20, 1996 | Substantially Equivalent |
| K960983 | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT | May 30, 1996 | Substantially Equivalent |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | Jan 22, 1996 | Substantially Equivalent |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | Nov 21, 1995 | Substantially Equivalent |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | Jul 25, 1995 | Substantially Equivalent |
| K950026 | MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER | Apr 5, 1995 | Substantially Equivalent |