FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHUNT ADAPTER
K Number: K813428
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
164
Review Days
23
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Basic Information
- Device Name
- SHUNT ADAPTER
- K Number
- K813428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- December 8, 1981
- Decision Date
- December 31, 1981
- Product Code
- FKN
- 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 |
|---|---|---|---|
| FKN | Adaptor, Shunt | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKN), ordered by most recent decision date.
DA-16 AND DA-24 SHUNT ADAPTERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
A-V SHUNT EXTENSION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Jan 25, 2001 | Substantially Equivalent |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | Aug 9, 2000 | Substantially Equivalent |
| 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 |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | 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 |