Vein Valve Cutter
FDA 510(k) K862724 · American Edwards Laboratories
510(k) numberK862724
Submission
- Device name
- Vein Valve Cutter
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- July 17, 1986
- Decision date
- January 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
| K862872 | Flexible Visualization CatheterFEI · Traditional | 10/24/1986SE |
Questions and answers
When was Vein Valve Cutter cleared by the FDA?
Vein Valve Cutter (K862724) received a 510(k) decision of Substantially Equivalent on January 2, 1987, 169 days after the submission was received.
What is the product code of K862724?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.