FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TORQUE HEX WRENCH
K Number: K875147
·
Decision Jan 27, 1988
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
1
Applicant Total
76
Review Days
43
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Basic Information
- Device Name
- TORQUE HEX WRENCH
- K Number
- K875147
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.3730
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- December 15, 1987
- Decision Date
- January 27, 1988
- Product Code
- DTF
- 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 |
|---|---|---|---|
| DTF | Tools, Pacemaker Service | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTF), ordered by most recent decision date.
View allOther Clearances by Cardiac Pacemakers, Inc.
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| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Jan 10, 1994 | Substantially Equivalent |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Oct 28, 1992 | Substantially Equivalent |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | Jun 17, 1991 | Substantially Equivalent |
| K905674 | LEAD STYLET | Jan 30, 1991 | Substantially Equivalent |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | Feb 23, 1990 | Substantially Equivalent |
| K894738 | MODEL 6888 LEAD TUNNELER | Sep 13, 1989 | Substantially Equivalent |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | Mar 10, 1989 | Substantially Equivalent |
| K872774 | BETATRON IV SYSTEM | Jan 5, 1988 | Substantially Equivalent |