FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNCARE TEMPORARY CARDIAC PACING WIRE
K Number: K861409
·
Decision May 5, 1986
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
5
Review Days
20
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Basic Information
- Device Name
- SYNCARE TEMPORARY CARDIAC PACING WIRE
- K Number
- K861409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gyneco, Inc.
- Date Received
- April 15, 1986
- Decision Date
- May 5, 1986
- 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 Gyneco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853216 | MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 | Apr 2, 1986 | Substantially Equivalent |
| K852357 | GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP | Jul 5, 1985 | Substantially Equivalent |
| K843941 | ENDOCYTE | Feb 25, 1985 | Substantially Equivalent |
| K841275 | FINE NEEDLE ASPIRATION DEVICE | Aug 17, 1984 | Substantially Equivalent |