510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982945Substantially Equivalent

Dual Purpose Closed Catheter

Spirit Medical Systems, Inc., Parker CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982945 is the FDA 510(k) clearance record for DUAL PURPOSE CLOSED CATHETER, a class I device, cleared for Spirit Medical Systems, Inc. on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list one 510(k) clearance for Spirit Medical Systems, Inc. As of , FDA records show no recalls naming K982945.

Clearance record

Decision date
Received
(32 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Spirit Medical Systems, Inc. 16267 Whitestone Dr., Parker CO
510(k) summary
Summary
Third party review
No

Clearances, product code BSY

Trailing 12 months

FDA records hold no clearances under product code BSY in the trailing twelve months.

FDA records show no clearances under product code BSY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260