Product Code: FKW
FDA class 2
21 CFR 876.5540
Tip, Vessel
Gastroenterology, Urology
The Vessel Tip is a component affixed to the end of a cannula or catheter to facilitate insertion into a blood vessel during vascular access procedures used in dialysis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKW, regulated under 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is flagged as an implant.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
10
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Basic Information
- Product Code
- FKW
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893438 | T SERIES VESSEL TIPS | Jun 08, 1989 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K810257 | VESSEL TIPS, SIZES 13-18 | Mar 13, 1981 | Substantially Equivalent | Quinton, Inc. |
| K791645 | VICKERS MEDICAL MODEL 112 TREONIC DC2 | Oct 02, 1979 | Substantially Equivalent | Vickers America Medical Corp. |