FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
K Number: K993816
·
Decision May 4, 2000
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
11
Review Days
176
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Basic Information
- Device Name
- BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- K Number
- K993816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Edwards
- Date Received
- November 10, 1999
- Decision Date
- May 4, 2000
- 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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| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Mar 23, 1993 | Substantially Equivalent |