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FDA 510(k)

CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER

K-Number: K981601 · 1998-07-28

ApplicantSorin Group Italia S.R.L.
Decision Date1998-07-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 1998-07-28 under 510(k) number K981601. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER?

CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER is a medical device that received FDA 510(k) clearance on 1998-07-28. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K981601.

When did CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER receive FDA 510(k) clearance?

CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER received FDA 510(k) clearance on 1998-07-28, under 510(k) number K981601.

Who is the listed applicant for CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER?

The FDA product code for CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER is DWF.

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Related Devices (Code: DWF)

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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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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