Rotating Hemostatic Valve
FDA 510(k) K890800 · Datascope Corp.
510(k) numberK890800
Submission
- Device name
- Rotating Hemostatic Valve
- Applicant
- Datascope Corp.
Oakland, NJ, US - Received
- February 16, 1989
- Decision date
- June 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
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Questions and answers
When was Rotating Hemostatic Valve cleared by the FDA?
Rotating Hemostatic Valve (K890800) received a 510(k) decision of Substantially Equivalent on June 12, 1989, 116 days after the submission was received.
What is the product code of K890800?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.