Home / 510(k) Clearances / K861165

510(k) K861165

PHARMASEAL DUAL LUMEN CATHETER by American Pharmaseal Div. Ahsc — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1986
Date Received
March 28, 1986
Clearance Type
Traditional
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 American Pharmaseal Div. Ahsc

  • K874022 — PHARMASEAL WOUND IRRIGATION DEVICE (December 30, 1987)
  • K874517 — PHARMASEAL RUBBER URETHRAL CATHETER (December 3, 1987)
  • K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (December 3, 1987)
  • K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE (November 6, 1987)
  • K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (September 4, 1987)
  • K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER (August 11, 1987)
  • K871429 — ANTIMICROBIAL FOLEY CATHETER (August 10, 1987)
  • K871770 — AMERICAN PHARMASEAL WOUND DRESSING (June 26, 1987)
  • K870387 — EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (May 8, 1987)
  • K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (April 1, 1987)

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)