FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
K Number: K121404
·
Decision May 3, 2013
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
8
Review Days
358
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Basic Information
- Device Name
- SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
- K Number
- K121404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Onset Medical Corporation
- Date Received
- May 10, 2012
- Decision Date
- May 3, 2013
- 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 Onset Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K152498 | SoloPath Re-Collapsible Access System | Jan 5, 2016 | Substantially Equivalent |
| K112629 | ONSET ACCESS CATHETER SYSTEM | Oct 11, 2011 | Substantially Equivalent |
| K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | Aug 2, 2010 | Substantially Equivalent |
| K092014 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | Oct 8, 2009 | Substantially Equivalent |
| K062852 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 | Feb 23, 2007 | Substantially Equivalent |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | May 2, 2006 | Substantially Equivalent |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | Feb 10, 2005 | Substantially Equivalent |