FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUINTON WHITE SEALING CAP
K Number: K850369
·
Decision Feb 15, 1985
Classifications
1
FEI Numbers
212
Registration Numbers
213
Same Product Code
496
Applicant Total
164
Review Days
15
Basic Information
- Device Name
- QUINTON WHITE SEALING CAP
- K Number
- K850369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- QUINTON, INC.
- Date Received
- January 31, 1985
- Decision Date
- February 15, 1985
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by QUINTON, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | Sep 5, 2003 | Substantially Equivalent |
| K021906 | QUINTON Q-CATH, MODEL 000460 | Sep 4, 2002 | Substantially Equivalent |
| 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 |