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510(k) K153459

TACVAC by Athena Gtx — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2016
Date Received
December 1, 2015
Clearance Type
Abbreviated
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 Athena Gtx

  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)
  • K191989 — WVSM (Wireless Vital Signs Monitor) RWC + miniCap (January 29, 2020)
  • K173203 — Athena GTX Device Management Suite (ADMS) Software (March 14, 2018)
  • K160582 — WiCap (September 2, 2016)
  • K130957 — WVSM (WIRLESS VITAL SIGNS MONITOR) (April 30, 2013)
  • K113165 — MINI-MEDIC (February 2, 2012)
  • K101674 — WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 (July 21, 2010)

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)