FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SUREFLEX STEERABLE GUIDING SHEATH KIT
K Number: K122926
·
Decision Jan 24, 2013
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
28
Review Days
122
Basic Information
- Device Name
- SUREFLEX STEERABLE GUIDING SHEATH KIT
- K Number
- K122926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAYLIS MEDICAL CO., INC.
- Date Received
- September 24, 2012
- Decision Date
- January 24, 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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