Uresil Valve Cutter
FDA 510(k) K905528 · Uresil Corp.
510(k) numberK905528
Submission
- Device name
- Uresil Valve Cutter
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- December 10, 1990
- Decision date
- April 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWQ – Stripper, Vein, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| K872157 | Hall Vein StripperDWQ · Traditional | Solco Basle, Inc. | 07/07/1987SE |
| K811910 | Vein-Trap TMDWQ · Traditional | Atrium Medical Corp. | 07/20/1981SE |
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| K980889 | Uresil Nephro-Ureteral StentLJE · Traditional | 04/08/1998SE |
| K972582 | Uresil GuidewireFGE · Traditional | 11/21/1997SE |
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Questions and answers
When was Uresil Valve Cutter cleared by the FDA?
Uresil Valve Cutter (K905528) received a 510(k) decision of Substantially Equivalent on April 18, 1991, 129 days after the submission was received.
What is the product code of K905528?
The FDA product code is DWQ – Stripper, Vein, External, a Class II (moderate risk) device regulated under 21 CFR 870.4885.