FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SDC VASCULAR TIES
K Number: K833355
·
Decision Jan 27, 1984
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
9
Review Days
121
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Basic Information
- Device Name
- SDC VASCULAR TIES
- K Number
- K833355
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Science Development Corp.
- Date Received
- September 28, 1983
- Decision Date
- January 27, 1984
- Product Code
- KDC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
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THERMUFF BAG
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MANUAL SURGICAL INSTRUMENTS
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DISPOSABLE CAUTERY ABRASIVE PAD
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INSTRUMENT ORGANIZER
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Other Clearances by Science Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843617 | SDC SILICONE SUMP DRAIN | Oct 24, 1984 | Substantially Equivalent |
| K842491 | SDC SILICONE FORCEP SHODS PRODUCT | Aug 10, 1984 | Substantially Equivalent |
| K832090 | SCD SKIN TEMP. SENSORS #3400 ETC | Oct 31, 1983 | Substantially Equivalent |
| K832391 | QT-100 ELECTRONIC TEMP. MONITOR | Sep 12, 1983 | Substantially Equivalent |
| K832392 | SDC ORAL-RECTAL TEMP. PROBE | Sep 12, 1983 | Substantially Equivalent |
| K830353 | ESOPHAGEAL PROBE W/TEMP. INDICATOR | Apr 6, 1983 | Substantially Equivalent |
| K830329 | ESOPHAGEAL STETHOSCOPE | Mar 11, 1983 | Substantially Equivalent |
| K830039 | SDC RECTAL TEMP. PROBE PRODUCT #1020 | Feb 23, 1983 | Substantially Equivalent |