FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMERE DELIVERY SHEATH, MODEL PDS
K Number: K043084
·
Decision May 2, 2005
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
5
Review Days
175
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Basic Information
- Device Name
- PREMERE DELIVERY SHEATH, MODEL PDS
- K Number
- K043084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Velocimed, Inc.
- Date Received
- November 8, 2004
- Decision Date
- May 2, 2005
- 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 Velocimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052523 | PROXIS SYSTEM | Sep 7, 2006 | Substantially Equivalent |
| K042117 | PROXIS SYSTEM, MODEL EPS 101 | Jan 7, 2005 | Substantially Equivalent |
| K042910 | VENTURE WIRE CONTROL CATHETER, MODEL WCC | Nov 22, 2004 | Substantially Equivalent |
| K040922 | VENTURE WIRE CONTROL CATHETER | Aug 18, 2004 | Substantially Equivalent |