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

Non-Bronchoscopic Bronchoalveolar Lavage Catheter

21 CFR 868.6810 / Anesthesiology
FDA source (opens on fda.gov)

OYI is the FDA product code for Non-Bronchoscopic Bronchoalveolar Lavage Catheter, a class I device type, regulated under 21 CFR 868.6810. FDA's definition for this code reads: "To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OYI
Device name
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
FDA definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OYI

By decision year
1 clearance under product code OYI with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYI by decision year
YearClearances
20111

Applicants with the most clearances

Product code OYI
Applicants holding the most 510(k) clearances under product code OYI
ApplicantClearances
Kimberly-Clark Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code