FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sterile Dilator
K Number: K192195
·
Decision Sep 26, 2019
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
14
Review Days
44
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Basic Information
- Device Name
- Sterile Dilator
- K Number
- K192195
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galt Medical Corp.
- Date Received
- August 13, 2019
- Decision Date
- September 26, 2019
- Product Code
- DRE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Galt Medical Corp.
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|---|---|---|---|
| K182660 | GaltTWS | May 30, 2019 | Substantially Equivalent |
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| K172487 | Coaxial Dilator Set (Micro-Introducer) | Oct 16, 2017 | Unknown |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Jul 5, 2016 | Substantially Equivalent |
| K152528 | Attachable Cath Lab Hemostasis Valve | Dec 2, 2015 | Substantially Equivalent |
| K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER | Aug 21, 2014 | Substantially Equivalent |
| K123430 | MICROSLIDER TEARAWAY INTRODUCER SET | Apr 12, 2013 | Substantially Equivalent |
| K071330 | GALTSTICK INTRODUCER SYSTEM | Oct 31, 2007 | Substantially Equivalent |
| K043525 | CATHETER INTRODUCER | Feb 9, 2005 | Substantially Equivalent |
| K033542 | EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE | Dec 5, 2003 | Substantially Equivalent |