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FDA 510(k)

KALIX II IMPLANT, MODEL 141 0XX WITH XX

K-Number: K053093 · 2005-12-07

ApplicantNew Deal, S.A.
Decision Date2005-12-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KALIX II IMPLANT, MODEL 141 0XX WITH XX is the device name listed in this FDA 510(k) record. The listed applicant is New Deal, S.A.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K053093. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALIX II IMPLANT, MODEL 141 0XX WITH XX?

KALIX II IMPLANT, MODEL 141 0XX WITH XX is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is New Deal, S.A.. The 510(k) number is K053093.

When did KALIX II IMPLANT, MODEL 141 0XX WITH XX receive FDA 510(k) clearance?

KALIX II IMPLANT, MODEL 141 0XX WITH XX received FDA 510(k) clearance on 2005-12-07, under 510(k) number K053093.

Who is the listed applicant for KALIX II IMPLANT, MODEL 141 0XX WITH XX?

The FDA 510(k) record lists New Deal, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALIX II IMPLANT, MODEL 141 0XX WITH XX?

The FDA product code for KALIX II IMPLANT, MODEL 141 0XX WITH XX is HWC. This falls under the Cardiovascular category.

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Other records listing New Deal, S.A. 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.

K070241MODIFICATION TO LAPIDUS PLATEK063820LISFRANC PLATEK070160MODIFICATION TO TTC PLATESK060474LISFRANC PLATEK061765KALIX II IMPLANTK061594LARGE UNI-CLIP STAPLE

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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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