Home / 510(k) Clearances / K140080

510(k) K140080

ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB by Codman & Shurtleff, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2014
Date Received
January 14, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Codman & Shurtleff, Inc.

  • K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (July 20, 2020)
  • K191237 — CERENOVUS Large Bore Catheter (November 8, 2019)
  • K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLin (November 8, 2017)
  • K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage Sy (October 16, 2017)
  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
  • K171862 — GALAXY G3 Mini Microcoil Delivery System (September 25, 2017)
  • K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stre (July 14, 2017)
  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)