510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903503Substantially Equivalent

Scimed Encore Inflation Device, Model Sm2500

Scimed, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903503 is the FDA 510(k) clearance record for SCIMED ENCORE INFLATION DEVICE, MODEL SM2500, a class II device, cleared for Scimed on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 8 510(k) clearances for Scimed, from to . As of , FDA records show no recalls naming K903503.

Clearance record

Decision date
Received
(67 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed 6655 Wedgewood Rd., Maple Grove 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