510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910205Substantially Equivalent

Lp-60 Low Pressure Inflation Device

Devices for Vascular Intervention, Inc., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910205 is the FDA 510(k) clearance record for LP-60 LOW PRESSURE INFLATION DEVICE, a class II device, cleared for Devices For Vascular Intervention, Inc. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 14 510(k) clearances for Devices For Vascular Intervention, Inc., from to . As of , FDA records show no recalls naming K910205.

Clearance record

Decision date
Received
(40 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Devices For Vascular Intervention, Inc. 595 Penobscot Dr., Redwood City CA
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260