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
K112541Substantially Equivalent

Z Flex-270Tm Steerable Sheath

Great Batch Medical, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112541 is the FDA 510(k) clearance record for Z FLEX-270TM STEERABLE SHEATH, a class II device, cleared for Great Batch Medical on under FDA product code DRA (Catheter, Steerable). FDA records list 10 510(k) clearances for Great Batch Medical, from to . As of , FDA records show one recall naming K112541.

Clearance record

Decision date
Received
(159 days to decision)
Product code
DRA Catheter, Steerable
Regulation
21 CFR 870.1280
Device class
Class II
Review panel
Cardiovascular
Applicant
Great Batch Medical 2300 Berkshire Ln. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRA

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