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

Implanted Subcutaneous Securement Catheter

21 CFR 880.5970 / General Hospital
FDA source (opens on fda.gov)

OKC is the FDA product code for Implanted Subcutaneous Securement Catheter, a class II device type, regulated under 21 CFR 880.5970. FDA's definition for this code reads: "Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OKC
Device name
Implanted Subcutaneous Securement Catheter
FDA definition
Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code OKC

By decision year
5 clearances under product code OKC with a decision year between 2008 and 2021, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OKC by decision year
YearClearances
20081
20091
20121
20181
20211

Applicants with the most clearances

Product code OKC
Applicants holding the most 510(k) clearances under product code OKC
ApplicantClearances
Interrad Medical Inc5

Companies listing this code with FDA

Companies whose registered establishments list this code