FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO MEDAMICUS AXIA RSN
K Number: K022689
·
Decision Aug 23, 2002
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
20
Review Days
10
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Basic Information
- Device Name
- MODIFICATION TO MEDAMICUS AXIA RSN
- K Number
- K022689
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medamicus, Inc.
- Date Received
- August 13, 2002
- Decision Date
- August 23, 2002
- 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 Medamicus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040150 | MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Feb 18, 2004 | Substantially Equivalent |
| K030905 | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER | Apr 9, 2003 | Substantially Equivalent |
| K021004 | VALVED PEELABLE INTRODUCER | Jun 6, 2002 | Substantially Equivalent |
| K020563 | MEDAMICUS AXIA RSN | May 21, 2002 | Substantially Equivalent |
| K013120 | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | Jan 24, 2002 | Substantially Equivalent |
| K011085 | GUIDEWIRE INTRODUCER SAFETY NEEDLE | Jul 9, 2001 | Substantially Equivalent |
| K000824 | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX | Apr 13, 2000 | Substantially Equivalent |
| K994097 | MEDAMICUS EPIDURAL INTRODUCER | Mar 1, 2000 | Substantially Equivalent |
| K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | Jun 28, 1999 | Substantially Equivalent |
| K965167 | PERCUTANEOUS VENOUS INTRODUCER 10264 | Jul 25, 1997 | Substantially Equivalent |