LP-60 Low Pressure Inflation Device
FDA 510(k) K910205 · Devices For Vascular Intervention, Inc.
510(k) numberK910205
Submission
- Device name
- LP-60 Low Pressure Inflation Device
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- January 16, 1991
- Decision date
- February 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FLIT · Traditional | 09/26/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was LP-60 Low Pressure Inflation Device cleared by the FDA?
LP-60 Low Pressure Inflation Device (K910205) received a 510(k) decision of Substantially Equivalent on February 25, 1991, 40 days after the submission was received.
What is the product code of K910205?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.