FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
K Number: K022257
·
Decision Oct 4, 2002
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
- K Number
- K022257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vomed Volzer Medizintechnik GmbH & Co.
- Date Received
- July 12, 2002
- Decision Date
- October 4, 2002
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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