FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAFT TUNNELER
K Number: K790124
·
Decision Feb 8, 1979
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
30
Review Days
16
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Basic Information
- Device Name
- GRAFT TUNNELER
- K Number
- K790124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Narco Scientific
- Date Received
- January 23, 1979
- Decision Date
- February 8, 1979
- Product Code
- DWS
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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|---|---|---|---|
| K830338 | NARCOTRACE 80 | Dec 22, 1983 | Substantially Equivalent |
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| K822835 | PZ-800 VOLUME VENTILATOR | Sep 29, 1983 | Substantially Equivalent |
| K831430 | AIR SHIELDS AS-100 MONIORING SYS-AS105 | Sep 12, 1983 | Substantially Equivalent |
| K831460 | AS 30/TCP MODULE | Jul 12, 1983 | Substantially Equivalent |
| K830123 | DISP. YANKAVER SURG. SUCTION INSTRUMENT | Jun 8, 1983 | Substantially Equivalent |
| K831028 | TI-1000 TRANSPORT INCUBATOR | May 9, 1983 | Substantially Equivalent |
| K823899 | INFANT CARE SYSTEM | Apr 14, 1983 | Substantially Equivalent |
| K830680 | AIR-SHIELDS VENTIMETER VENTILATOR-CONTR | Apr 8, 1983 | Substantially Equivalent |