FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Y-GLIDE
K Number: K072745
·
Decision Jan 4, 2008
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
23
Review Days
99
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Basic Information
- Device Name
- Y-GLIDE
- K Number
- K072745
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thomas Medical Products, Inc.
- Date Received
- September 27, 2007
- Decision Date
- January 4, 2008
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Thomas Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122431 | HEARTSPAN STEERABLE INTRODUCER KIT | Jan 29, 2013 | Substantially Equivalent |
| K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS | Aug 14, 2012 | Substantially Equivalent |
| K101015 | GUIDE CATHETERS AND ACCESSORIES | Sep 23, 2010 | Substantially Equivalent |
| K083269 | CROSSOVER | Feb 3, 2009 | Substantially Equivalent |
| K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) | May 14, 2008 | Substantially Equivalent |
| K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT | Feb 15, 2005 | Substantially Equivalent |
| K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM | Jun 1, 2004 | Substantially Equivalent |
| K011727 | TRANSSEPTAL NEEDLE/TROCAR | May 2, 2002 | Substantially Equivalent |
| K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET | Feb 11, 2002 | Substantially Equivalent |
| K013202 | MODIFICATION TO BRAIDED GUIDING INTRODUCER | Oct 23, 2001 | Substantially Equivalent |