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510(k) K770149

MAJOR SUTURE REMOVAL TRAY by Pharmaseal Div., Baxter Healthcare Corp. — Product Code KDD

K770149 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "MAJOR SUTURE REMOVAL TRAY". The FDA issued a decision of Substantially Equivalent on February 25, 1977. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Pharmaseal Div., Baxter Healthcare Corp.

  • K792369 — HYPERALIMENTATION DRESSING TRAY (December 10, 1979)
  • K792141 — CONTINUOUS FLUSH DEVICE (December 5, 1979)
  • K792019 — PHADECODE XA INHIBITOR ASSAY (November 5, 1979)
  • K791773 — VENTILATOR TUBE WITH FILTER (October 22, 1979)
  • K791156 — AMIPAQUE MYELOGRAM TRAY (July 30, 1979)
  • K790896 — TWO-WAY ANESTHESIA FILTER (June 5, 1979)
  • K790409 — LOW DEAD SPACE INSULIN SYRINGE (April 24, 1979)
  • K782069 — TRAY, AUXILLARY BLOCK (January 4, 1979)
  • K781797 — PREP TRAY, PREOPERATIVE SKIN (November 8, 1978)
  • K781680 — MONITORING, PRESSURE KIT (October 6, 1978)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources