FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL TIPS, SIZES 13-18
K Number: K810257
·
Decision Mar 13, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
164
Review Days
42
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Basic Information
- Device Name
- VESSEL TIPS, SIZES 13-18
- K Number
- K810257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- January 30, 1981
- Decision Date
- March 13, 1981
- Product Code
- FKW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKW | Tip, Vessel | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKW), ordered by most recent decision date.
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| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | Aug 13, 1997 | Substantially Equivalent |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
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