Company ยท US
Galt Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2019. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
22recalls (1 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 15 |
| DQX | Wire, Guide, Catheter | 6 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 6 |
| KGZ | Accessories, Catheter | 5 |
| OFL | Percutaneous Sheath Introducer Kit | 2 |
| DRB | Stylet, Catheter | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 26, 2019 | K192195 | Sterile Dilator Galt Medical Corp. | DRE |
| May 30, 2019 | K182660 | GaltTWS Galt Medical Corp. | DRB |
| Dec 21, 2017 | K173287 | Elite HV Radial Galt Medical Corp. | DYB |
| Oct 16, 2017 | K172487 | Coaxial Dilator Set (Micro-Introducer) Galt Medical Corp. | DRE |
| Jul 5, 2016 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer Galt Medical Corp. | DYB |
| Dec 2, 2015 | K152528 | Attachable Cath Lab Hemostasis Valve Galt Medical Corp. | DTL |
| Aug 21, 2014 | K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER Galt Medical Corp. | DYB |
| Apr 12, 2013 | K123430 | MICROSLIDER TEARAWAY INTRODUCER SET Galt Medical Corp. | DYB |
| Apr 12, 2012 | K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT Galt Medical | DYB |
| Oct 31, 2007 | K071330 | GALTSTICK INTRODUCER SYSTEM Galt Medical Corp. | DRE |
| Feb 9, 2005 | K043525 | CATHETER INTRODUCER Galt Medical Corp. | DYB |
| Dec 5, 2003 | K033542 | EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE Galt Medical Corp. | DQX |
| Jul 17, 2003 | K031916 | GALT MEDICAL GUIDEWIRE Galt Medical Corp. | DQX |
| Jul 18, 2002 | K021990 | GALT MEDICAL GUIDEWIRE Galt Medical Corp. | DQX |
| Feb 1, 1999 | K982559 | GUIDEWIRE Galt Medical Corp. | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Galt Medical Corporation Boston Scientific Enhance Transcarotid/Peripheral Access Kit
REF: SR-4F21G7D-MP (Kit-075-03)
Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube Open, Classified |
DQX | K000737 K021990 |
| May 7, 2025 | Galt Medical Corporation Introducer Kit- Tearaway MicroSlide
REF
KIT-051-01, 00841268106130
INT-101-15, 00841268107380
These introducers are used for the procedures to introduce catheters and other intravascular devices into Open, Classified |
OFL | None listed |
| May 7, 2025 | Galt Medical Corporation Introducer Needle
REF NDL-107-04
These needles are used for the percutaneous introduction of guidewires Open, Classified |
DWS | None listed |
| May 7, 2025 | Galt Medical Corporation Introducer Kit- Coaxial Dilator
REF:
KIT-002-28, 00841268104730
KIT-002-34, 00841268104792
KIT-002-35, 00841268104808
KIT-011-40, 00841268105553
KIT-011-62, 00841268105614
KIT-038-04, 00841268104556
K Open, Classified |
OFL | None listed |
| May 7, 2025 | Galt Medical Corporation GALT Guidewire
REF SGW-051-07
Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vascu Open, Classified |
DQX | K982559 |
| May 7, 2025 | Galt Medical Corporation B Braun Interventional ELITE HV Hemostasis Valve Introducer System
REF 612802
Model Number: BCL-100-04
The Elite HV Introducer System is indicated for use in percutaneous
procedures to introduce cath Open, Classified |
DYB | K043525 |
| May 7, 2025 | Galt Medical Corporation B Braun Interventional Coaxial Dilator
REF:
KIT-018-47,
KIT-019-67,
KIT-018-41,
KIT-019-37
These Micro-Introducer Kits are intended to introduce up to a .038 inch
guidewire or catheter into the vascu Open, Classified |
DRE | K000737 |
| May 7, 2025 | Galt Medical Corporation GALT Centeze Catheter
REF:
DRC-002-05
DRC-002-06
The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups. Open, Classified |
KGZ | None listed |
| Jun 15, 2023 | Galt Medical Corporation Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk) Open, Classified |
DYB | K153533 |
| Jun 15, 2023 | Galt Medical Corporation Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 Open, Classified |
DYB | K153533 |
| Dec 14, 2020 | Galt Medical Corporation Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16 Terminated |
KGZ | None listed |
| May 2, 2018 | Galt Medical Corporation Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10;
c) DIL-015-50;
d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-04 Terminated |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation TVS LPA, Catalog #: DIL-059-00 Terminated |
KGZ | K000737 K172487 |
| May 2, 2018 | Galt Medical Corporation Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, Terminated |
KGZ | None listed |
| May 2, 2018 | Galt Medical Corporation Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055 Terminated |
DYB | K043525 K173287 |
| May 2, 2018 | Galt Medical Corporation 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11;
2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; Terminated |
DRE | K000737 K172487 |
| May 2, 2018 | Galt Medical Corporation 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a)
DRC-001-05, b) DRC-001-06, c) DRC-001-15,
2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05 Terminated |
KGZ | None listed |
| May 2, 2018 | Galt Medical Corporation 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12;
2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11;
3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) IN Terminated |
DYB | None listed |
| May 2, 2018 | Galt Medical Corporation 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36;
2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog Terminated |
DYB | K043525 K173287 |
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravasc Terminated |
DYB | K112398 |
| Sep 4, 2014 | Galt Medical Corporation GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO
Product Usage:
Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral Terminated |
DYB | K112398 |
| May 11, 2010 | Galt Medical Corp Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369. Terminated |
DRE | K000737 |