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FDA 510(k)

CUROS PORT PROTECTOR

K-Number: K111992 · 2012-01-12

ApplicantIvera Medical, Inc.
Decision Date2012-01-12
Product CodeQBP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUROS PORT PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ivera Medical, Inc.. It received FDA 510(k) clearance on 2012-01-12 under 510(k) number K111992. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUROS PORT PROTECTOR?

CUROS PORT PROTECTOR is a medical device that received FDA 510(k) clearance on 2012-01-12. The listed applicant is Ivera Medical, Inc.. The 510(k) number is K111992.

When did CUROS PORT PROTECTOR receive FDA 510(k) clearance?

CUROS PORT PROTECTOR received FDA 510(k) clearance on 2012-01-12, under 510(k) number K111992.

Who is the listed applicant for CUROS PORT PROTECTOR?

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

What is the FDA product code for CUROS PORT PROTECTOR?

The FDA product code for CUROS PORT PROTECTOR is QBP.

Related Clinical Trials

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.

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Other records listing Ivera 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.

K121171CUROS TIP

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Official Source

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

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