Rotating Hemostatic Valve
FDA 510(k) K883916 · Devices For Vascular Intervention, Inc.
510(k) numberK883916
Submission
- Device name
- Rotating Hemostatic Valve
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- September 16, 1988
- Decision date
- October 28, 1988
- 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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Questions and answers
When was Rotating Hemostatic Valve cleared by the FDA?
Rotating Hemostatic Valve (K883916) received a 510(k) decision of Substantially Equivalent on October 28, 1988, 42 days after the submission was received.
What is the product code of K883916?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.