FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAXIAL DILATOR SET
K Number: K000737
·
Decision Aug 1, 2000
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
2
Review Days
147
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Basic Information
- Device Name
- COAXIAL DILATOR SET
- K Number
- K000737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xentek Medical, Inc.
- Date Received
- March 7, 2000
- Decision Date
- August 1, 2000
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Xentek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000313 | TEARAWAY INTRODUCER SHEATH | Jun 16, 2000 | Substantially Equivalent |