Home / 510(k) Clearances / K173389

510(k) K173389

Rex Medical Aspiration Pump by Rex Medical, L.P. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2018
Date Received
October 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Rex Medical, L.P.

  • K212351 — Revolution Peripheral Atherectomy System (December 15, 2021)
  • K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guid (September 12, 2019)
  • K143405 — Option (TM) ELITE Vena Cava Filter 100cm System (April 16, 2015)
  • K141617 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (November 14, 2014)
  • K133243 — OPTION ELITE VENA CAVA FILTER SYSTEM (December 17, 2013)
  • K060904 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (April 28, 2006)
  • K042399 — MODIFICATION TO SHORT INTRODUCER SHEATH (December 17, 2004)

Other clearances for product code BTA

  • K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (June 6, 2025)
  • K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 (May 16, 2025)
  • K251101 — AIRO Suction Unit (AIRO-01) (April 26, 2025)
  • K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) (April 23, 2025)
  • K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose sys (March 7, 2025)
  • K243138 — Geon (S2) Nasal Aspirator (February 4, 2025)
  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
  • K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (November 19, 2024)
  • K241202 — Electric nasal aspirator (HTD2601US) (July 1, 2024)
  • K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 (March 20, 2024)