510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982272Substantially Equivalent

Galeo Hs 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo HF 018

BIOTRONIK AG, Lake Oswego OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982272 is the FDA 510(k) clearance record for GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018, a class II device, cleared for Biotronik, Inc. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 104 510(k) clearances for Biotronik, Inc., from to . As of , FDA records show no recalls naming K982272.

Clearance record

Decision date
Received
(193 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Biotronik, Inc. 6024 Jean Rd., Lake Oswego OR
510(k) summary
Summary
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to November 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20261
November 20260