Product code OKC— General Hospital

SecurAcath

Classification name: Implanted Subcutaneous Securement Catheter
Device class: Class 2
Regulation: 21 CFR 880.5970
Advisory panel: General Hospital
Total cleared: 5
First cleared: 2008-09-30
Most recent: 2021-04-12

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OKC under 21 CFR 880.5970, via openFDA

Market context for product code OKC

FDA has cleared 5 devices under product code OKC between 2008 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20211 clearance
20181 clearance
20121 clearance
20091 clearance
20081 clearance

Top applicants under product code OKC

Interrad Medical, Inc.5 clearances

Recent clearances under product code OKC

K210629 — SecurAcathInterrad Medical, Inc.·2021-04-12
K180769 — SecurAcathInterrad Medical, Inc.·2018-06-26
K120935 — SECURACATHInterrad Medical, Inc.·2012-04-27
K083081 — MODIFICATION TO SECURACATH, MODEL: SPK01Interrad Medical, Inc.·2009-03-04
K082047 — SECURACATH CATHETER, MODEL SPK01Interrad Medical, Inc.·2008-09-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.