FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL DELIVERY SYSTEM CATHETER
K Number: K900657
·
Decision May 9, 1990
Classifications
1
FEI Numbers
271
Registration Numbers
272
Same Product Code
880
Applicant Total
18
Review Days
89
Basic Information
- Device Name
- UNIVERSAL DELIVERY SYSTEM CATHETER
- K Number
- K900657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MICROVENA CORP.
- Date Received
- February 9, 1990
- Decision Date
- May 9, 1990
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by MICROVENA CORP.
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|---|---|---|---|
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| 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 |
| K954205 | THE AMPLATZ THROMBECTOMY DEVICE | Aug 13, 1996 | Substantially Equivalent |
| K955304 | CRICKET | May 16, 1996 | Substantially Equivalent |
| K952860 | THE NINER NITINOL GUIDEWIRE | Dec 13, 1995 | Substantially Equivalent |