Home / 510(k) Clearances / K933517

510(k) K933517

AUTOMATIC PULL BACK DEVICE by Cardiovascular Imaging Systems, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1993
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Cardiovascular Imaging Systems, Inc.

  • K970049 — BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULT (June 20, 1997)
  • K942231 — MICROVIEW II/MICRORAIL II CATHETERS (August 1, 1994)
  • K930232 — CVIS INSIGHT IMAGING GUIDE CATHETER (July 21, 1993)
  • K924922 — CVIS INSIGHT IMAGING CATHETER (June 29, 1993)
  • K930311 — CVIS LONGVIEW (June 2, 1993)
  • K921879 — CBIS CATHETER PULL-BACK DEVICE (July 16, 1992)
  • K921750 — CVIS INSIGHT III SYSTEM (July 13, 1992)
  • K921631 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL (July 2, 1992)
  • K921147 — CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE (June 16, 1992)
  • K921148 — CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE (June 16, 1992)

Other clearances for product code DQX

  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)