FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STIFF STYLETS
K Number: K802076
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
27
Applicant Total
76
Review Days
29
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Basic Information
- Device Name
- STIFF STYLETS
- K Number
- K802076
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- August 28, 1980
- Decision Date
- September 26, 1980
- Product Code
- DRB
- 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 |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
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STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Cardiac Pacemakers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K080154 | ACUITY UNIVERSAL CUTTER | Mar 20, 2008 | Substantially Equivalent |
| 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 |
| K875147 | TORQUE HEX WRENCH | Jan 27, 1988 | Substantially Equivalent |