Dilator, Vessel
The Vessel Dilator is a urological device used to gradually widen a blood vessel or lumen to facilitate catheter or cannula insertion during vascular access procedures. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKA, regulated under 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- FKA
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
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 |
|---|---|---|---|---|
| K022620 | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT | Oct 11, 2002 | Substantially Equivalent | Spire Biomedical, Inc. |
| K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR | Jul 01, 1993 | Substantially Equivalent | Vas-Cath, Inc. |
| K910502 | VESSEL DILATORS | Apr 29, 1991 | Substantially Equivalent | Akcess Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.