Securacath Catheter, Model SPK01

by Interrad Medical, Inc. 510(k)

Active United States

510(k) K082047

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082047	Date30 Sep 2008Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 10 Oct 2026)

Specification

510(k)

510(k) Number: K082047
FDA Product Code: OKC

Device Class: Class II
Regulation: 21 CFR Part 880.5970
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

Other devices from Interrad Medical, Inc.

SecurAcath

Class IIb
SecurAcath 12F

Class II
SecurAcath 8F

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Securacath Universal

Class II
Modification to Securacath, Model: SPK01

Class II
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

Class I

See all devices from Interrad Medical, Inc. →