FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALTSTICK INTRODUCER SYSTEM
K Number: K071330
·
Decision Oct 31, 2007
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
14
Review Days
173
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GALTSTICK INTRODUCER SYSTEM
- K Number
- K071330
- 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
- May 11, 2007
- Decision Date
- October 31, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.
ProtekDilate Vascular Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Gold Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Galt Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K192195 | Sterile Dilator | Sep 26, 2019 | Substantially Equivalent |
| K182660 | GaltTWS | May 30, 2019 | Substantially Equivalent |
| K173287 | Elite HV Radial | Dec 21, 2017 | Unknown |
| 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 |
| K043525 | CATHETER INTRODUCER | Feb 9, 2005 | Substantially Equivalent |
| K033542 | EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE | Dec 5, 2003 | Substantially Equivalent |