Home / 510(k) Clearances / K891388

510(k) K891388

1570 - FETAL BLOOD SAMPLING KIT by Transidyne General Corp. — Product Code HGW

K891388 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "1570 - FETAL BLOOD SAMPLING KIT". The FDA issued a decision of Substantially Equivalent on March 28, 1989. The device falls under product code HGW (Sampler, Blood, Fetal), a Class II device regulated under 21 CFR 884.1560. Transidyne General Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1989
Date Received
March 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Blood, Fetal
Device Class
Class II
Regulation Number
884.1560
Review Panel
OB
Submission Type

Other clearances by Transidyne General Corp.

  • K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
  • K955658 — LACERATION TRAY (January 25, 1996)
  • K950773 — PROPHYLAXIS PACK (March 31, 1995)
  • K950743 — ORAL PROCEDURE PACK (March 31, 1995)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)

Other clearances for product code HGW

  • K884685 — ROCKET FETAL BLOOD SAMPLING TRAY (January 12, 1989)
  • K831459 — FETAL BLOOD SAMPLING KIT #1560 (June 30, 1983)
  • K810028 — FETAL BLOOD SAMPLING KIT MODEL 1560 (January 16, 1981)

FDA data resources