FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
K Number: K071125
·
Decision Jun 18, 2007
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
14
Review Days
56
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Basic Information
- Device Name
- AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
- K Number
- K071125
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aga Medical Corp.
- Date Received
- April 23, 2007
- Decision Date
- June 18, 2007
- Product Code
- KRD
- 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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Other Clearances by Aga Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K113658 | AMPLATZER VASCULAR PLUG 4 | Jun 12, 2012 | Substantially Equivalent |
| K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 | Feb 5, 2010 | Substantially Equivalent |
| K091793 | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 | Jul 9, 2009 | Substantially Equivalent |
| K083214 | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 | May 12, 2009 | Substantially Equivalent |
| K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM | May 16, 2008 | Substantially Equivalent |
| K080757 | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM | Apr 18, 2008 | Substantially Equivalent |
| K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM | Nov 2, 2007 | Substantially Equivalent |
| K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aug 15, 2007 | Substantially Equivalent |
| K070238 | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM | Feb 28, 2007 | Substantially Equivalent |
| K053187 | AMPLATZER NOODLEWIRE GUIDEWIRE | Apr 27, 2006 | Substantially Equivalent |