FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED USE OF PULL-APART INTRODUCER SET
K Number: K871730
·
Decision May 18, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
15
Applicant Total
164
Review Days
13
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Basic Information
- Device Name
- MODIFIED USE OF PULL-APART INTRODUCER SET
- K Number
- K871730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- May 5, 1987
- Decision Date
- May 18, 1987
- Product Code
- FKO
- 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 |
|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKO), ordered by most recent decision date.
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AMUKIN 50% - AIRSPRAY(R)
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FDA Class 2
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DIALY-NATE SET & DIALY-NATE CATHETER
FDA 510(k)
FDA Class 2
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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 |