FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K Number: K120158
·
Decision Aug 14, 2012
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
23
Review Days
209
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Basic Information
- Device Name
- CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
- K Number
- K120158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thomas Medical Products, Inc.
- Date Received
- January 18, 2012
- Decision Date
- August 14, 2012
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 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 |
| 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 |
| K072745 | Y-GLIDE | Jan 4, 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 |