FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
K Number: K924712
·
Decision Dec 8, 1992
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
11
Review Days
81
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Basic Information
- Device Name
- ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- K Number
- K924712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hearing Tech, Inc.
- Date Received
- September 18, 1992
- Decision Date
- December 8, 1992
- 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 Hearing Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941587 | HEARING TECH | Jun 24, 1994 | Substantially Equivalent |
| K905680 | 543 SERIES BTE | Mar 8, 1991 | Substantially Equivalent |
| K903295 | ESCORT ITC | Sep 5, 1990 | Substantially Equivalent |
| K903023 | HERITAGE III (HTC) ITC TYPE HEARING AID | Jul 27, 1990 | Substantially Equivalent |
| K870723 | HEARTECH HFX, HEARING AID | Mar 20, 1987 | Substantially Equivalent |
| K870350 | ESCORT EC CUSTOM IN-THE-EAR HEARING AID | Mar 11, 1987 | Substantially Equivalent |
| K854315 | HEARTECH MODEL IN TECH | Jan 21, 1986 | Substantially Equivalent |
| K853219 | HEARTECH MODEL CH | Sep 23, 1985 | Substantially Equivalent |
| K853218 | HEARTECH MODEL(HTC) (HERITAGE) | Sep 23, 1985 | Substantially Equivalent |
| K853220 | HEARTECH MODEL ILLUSION | Sep 23, 1985 | Substantially Equivalent |