FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEERABLE STYLET
K Number: K040001
·
Decision Mar 9, 2004
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
27
Applicant Total
8
Review Days
67
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Basic Information
- Device Name
- STEERABLE STYLET
- K Number
- K040001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Surgical Innovations
- Date Received
- January 2, 2004
- Decision Date
- March 9, 2004
- Product Code
- DRB
- 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 |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
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| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | Oct 27, 2004 | Substantially Equivalent |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | Apr 14, 2004 | Substantially Equivalent |
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| K030879 | VERITAS COLLAGEN MATRIX | Apr 24, 2003 | Substantially Equivalent |