FDA 510(k) clearance · back to tracker

Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

Cook Incorporated cleared K162729 on 2017-08-11, decision: substantially equivalent

K-number

K162729

Sponsor

Cook Incorporated

Device

Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

Class

Class I

Decision

Substantially Equivalent

Decision date

2017-08-11

Product code

BSR

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.5790

Official FDA record

Open K162729on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.