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510(k) K883888

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. by Advanced Biosearch Assn. — Product Code DXK

K883888 is an FDA 510(k) premarket notification submitted by Advanced Biosearch Assn. for the device "CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.". The FDA issued a decision of Substantially Equivalent on December 12, 1988. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Advanced Biosearch Assn. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1988
Date Received
September 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

Other clearances by Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855030 — CHAMPY BONE PLATES & BONE SCREWS (January 30, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K853418 — SAFTI-BRACELET (September 20, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)
  • K850773 — PM CEMENTLESS SCREW-IN ACETABULAR CUP (May 2, 1985)

Other clearances for product code DXK

  • K181042 — Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (May 17, 2018)
  • K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr (February 26, 2016)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K913209 — ACCESSORY TO GENESIS III (GCFM) (May 15, 1992)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
  • K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (April 22, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)

FDA data resources