FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K Number: K963073
·
Decision Aug 14, 1997
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
8
Review Days
412
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Basic Information
- Device Name
- HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
- K Number
- K963073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Harmac Medical Products, Inc.
- Date Received
- June 28, 1996
- Decision Date
- August 14, 1997
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Harmac Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021916 | HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 | Aug 29, 2002 | Substantially Equivalent |
| K963335 | HARMAC BALLOON WEDGE PRESSURE CATHETER | Oct 16, 1997 | Substantially Equivalent |
| K962829 | HARMAC BALLOON ANGIOGRAPHIC CATHETER | Oct 16, 1997 | Substantially Equivalent |
| K962833 | HARMAC TEMPORARY PACING CATHETER WITH BALLOON | Oct 15, 1997 | Substantially Equivalent |
| K963336 | HARMAC THERMODILUTION CATHETER | Aug 14, 1997 | Substantially Equivalent |
| K963074 | HARMAC QUADPOLAR MAPPING PACING CATHETER | Jun 25, 1997 | Substantially Equivalent |
| K950895 | HARMAC EXTENSION INFUSION SET | Sep 1, 1995 | Substantially Equivalent |