FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE AMPLATZ THROMBECTOMY DEVICE
K Number: K954205
·
Decision Aug 13, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
18
Review Days
341
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Basic Information
- Device Name
- THE AMPLATZ THROMBECTOMY DEVICE
- K Number
- K954205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microvena Corp.
- Date Received
- September 7, 1995
- Decision Date
- August 13, 1996
- Product Code
- MCW
- 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Microvena Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K991898 | ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE | Jun 16, 1999 | Substantially Equivalent |
| K991194 | MODIFICATION TO ULTRA-SELECT GUIDEWIRE | May 5, 1999 | Substantially Equivalent |
| K982657 | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 | Nov 18, 1998 | Substantially Equivalent |
| K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE | Jun 10, 1998 | Substantially Equivalent |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | Mar 6, 1998 | Substantially Equivalent |
| K971984 | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) | Sep 19, 1997 | Substantially Equivalent |
| K954642 | HYDRO-SELECT GUIDEWIRE | Dec 17, 1996 | Substantially Equivalent |
| K955304 | CRICKET | May 16, 1996 | Substantially Equivalent |
| K952860 | THE NINER NITINOL GUIDEWIRE | Dec 13, 1995 | Substantially Equivalent |
| K946356 | M-PATH NITINOL GUIDEWIRE | Mar 31, 1995 | Substantially Equivalent |