510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182660Substantially Equivalent

GaltTWS

Galt Medical Corp, Garland TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182660 is the FDA 510(k) clearance record for GaltTWS, a class II device, cleared for Galt Medical Corp. on under FDA product code DRB (Stylet, Catheter). FDA records list 15 510(k) clearances for Galt Medical Corp., from to . As of , FDA records show no recalls naming K182660.

Clearance record

Decision date
Received
(247 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Galt Medical Corp. 2220 Merritt Dr., Garland TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRB

Trailing 12 months

FDA records hold no clearances under product code DRB in the trailing twelve months.

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, 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 20260
October 20260