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FDA 510(k)

SECURACATH CATHETER, MODEL SPK01

K-Number: K082047 · 2008-09-30

ApplicantInterrad Medical, Inc.
Decision Date2008-09-30
Product CodeOKC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECURACATH CATHETER, MODEL SPK01 is the device name listed in this FDA 510(k) record. The listed applicant is Interrad Medical, Inc.. It received FDA 510(k) clearance on 2008-09-30 under 510(k) number K082047. The device is classified under product code OKC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECURACATH CATHETER, MODEL SPK01?

SECURACATH CATHETER, MODEL SPK01 is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Interrad Medical, Inc.. The 510(k) number is K082047.

When did SECURACATH CATHETER, MODEL SPK01 receive FDA 510(k) clearance?

SECURACATH CATHETER, MODEL SPK01 received FDA 510(k) clearance on 2008-09-30, under 510(k) number K082047.

Who is the listed applicant for SECURACATH CATHETER, MODEL SPK01?

The FDA 510(k) record lists Interrad Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECURACATH CATHETER, MODEL SPK01?

The FDA product code for SECURACATH CATHETER, MODEL SPK01 is OKC.

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Other records listing Interrad Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210629SecurAcathK180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FK180769SecurAcathK120935SECURACATHK092306SECURACATH UNIVERSALK083081MODIFICATION TO SECURACATH, MODEL: SPK01

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Related Devices (Code: OKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210629SecurAcathInterrad Medical, Inc.K180769SecurAcathInterrad Medical, Inc.K120935SECURACATHInterrad Medical, Inc.K083081MODIFICATION TO SECURACATH, MODEL: SPK01Interrad Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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