510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091761Substantially Equivalent

Teleflex Isis Hvt Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port

Teleflexmedical, Inc., Durham NC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091761 is the FDA 510(k) clearance record for TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT, a class II device, cleared for Teleflexmedical, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 64 510(k) clearances for Teleflexmedical, Inc., from to . As of , FDA records show 15 recalls naming K091761.

Clearance record

Decision date
Received
(135 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Teleflexmedical, Inc. 2917 Weck Dr., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTR

Trailing 12 months
2 clearances under product code BTR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260