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510(k) K870977

PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE by American Pharmaseal Div. Ahsc — Product Code KOD

K870977 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE". The FDA issued a decision of Substantially Equivalent on April 1, 1987. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1987
Date Received
March 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
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)
  • K870704 — CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET (March 27, 1987)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)

FDA data resources