FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
K Number: K954604
·
Decision Jan 18, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
3
Review Days
106
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Basic Information
- Device Name
- ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
- K Number
- K954604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heart Technology Mfg., Inc.
- Date Received
- October 4, 1995
- Decision Date
- January 18, 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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