510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843448Substantially Equivalent

Scimed Pm200 Inflation Manometer

Scimed Life Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843448 is the FDA 510(k) clearance record for SCIMED PM200 INFLATION MANOMETER, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K843448.

Clearance record

Decision date
Received
(48 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 13000 County Rd. 6, Minneapolis MN
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