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510(k) K833355

SDC VASCULAR TIES by Science Development Corp. — Product Code KDC

K833355 is an FDA 510(k) premarket notification submitted by Science Development Corp. for the device "SDC VASCULAR TIES". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Science Development Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
September 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Science Development Corp.

  • K843617 — SDC SILICONE SUMP DRAIN (October 24, 1984)
  • K842491 — SDC SILICONE FORCEP SHODS PRODUCT (August 10, 1984)
  • K832090 — SCD SKIN TEMP. SENSORS #3400 ETC (October 31, 1983)
  • K832392 — SDC ORAL-RECTAL TEMP. PROBE (September 12, 1983)
  • K832391 — QT-100 ELECTRONIC TEMP. MONITOR (September 12, 1983)
  • K830353 — ESOPHAGEAL PROBE W/TEMP. INDICATOR (April 6, 1983)
  • K830329 — ESOPHAGEAL STETHOSCOPE (March 11, 1983)
  • K830039 — SDC RECTAL TEMP. PROBE PRODUCT #1020 (February 23, 1983)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)

FDA data resources