FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
K Number: K854517
·
Decision Dec 2, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
206
Review Days
20
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Basic Information
- Device Name
- NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
- K Number
- K854517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- November 12, 1985
- Decision Date
- December 2, 1985
- Product Code
- FKK
- 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 |
|---|---|---|---|
| FKK | Clamp, Line | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKK), ordered by most recent decision date.
TUBING CLAMP CAT#1000-A
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EMPTY DIALYSATE CONTAINER
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AMP CAPD UNISPIKE AMINISTRATION SET
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·Gastroenterology, Urology
FLOWCLAMP CAT.#1011 & 1012
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Travenol Laboratories, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | Feb 22, 1988 | Substantially Equivalent |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | Nov 5, 1987 | Substantially Equivalent |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Oct 22, 1987 | Substantially Equivalent |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Oct 20, 1987 | Substantially Equivalent |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Oct 13, 1987 | Substantially Equivalent |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Sep 30, 1987 | Substantially Equivalent |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | Sep 4, 1987 | Substantially Equivalent |
| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |