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510(k) K910503

DISCOGRAPHY KIT by B. Braun of America, Inc. — Product Code IZG

K910503 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "DISCOGRAPHY KIT". The FDA issued a decision of Substantially Equivalent (kit) on October 7, 1991. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 7, 1991
Date Received
February 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type

Other clearances by B. Braun of America, Inc.

  • K993024 — CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (March 13, 2000)
  • K983794 — CHEMO MINI SPIKE PLUS (March 23, 1999)
  • K946170 — COMFORT-Q SUBCUTANEOUS INJECTION SETS (November 3, 1995)
  • K945850 — BRAUN DIACAN(R) FISTULA NEEDLES (October 6, 1995)
  • K942988 — FILTERED EXTENSION SETS (July 14, 1995)
  • K945752 — CELSITE(TM) BRACHIAL VENOUS PORT (May 31, 1995)
  • K945551 — CELSITE(TM) DUAL VENOUS SYSTEM (April 21, 1995)
  • K943770 — LOW VOLUME MULTIPORT (April 10, 1995)
  • K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (April 4, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)

Other clearances for product code IZG

  • K960082 — DISCOGRAPHY KIT (March 21, 1996)
  • K960146 — G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (February 27, 1996)
  • K913436 — PXI PNEUMATIC COMPRESSION PADDLE (November 5, 1992)
  • K920393 — MU125M MOBILE X-RAY SYSTEM (April 6, 1992)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

FDA data resources