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510(k) K822158

OPEN HEART TRAY (CUSTOM DESIGNED) by Megaplast, Inc. — Product Code KDD

K822158 is an FDA 510(k) premarket notification submitted by Megaplast, Inc. for the device "OPEN HEART TRAY (CUSTOM DESIGNED)". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Megaplast, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
July 23, 1982
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 Megaplast, Inc.

  • K821313 — SURGICAL UTILITY DRAPE (June 21, 1982)
  • K820423 — SUTURE REMOVAL TRAY (March 10, 1982)
  • K820136 — URINARY DRAINAGE BAG (January 29, 1982)
  • K810249 — TRAY, CATHERIZATION, URETHRAL (April 7, 1981)
  • K810250 — TRAY, IRRIGATION (April 7, 1981)
  • K810251 — SYRINGE, ENT (March 11, 1981)

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