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FDA 510(k)

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

K-Number: K103215 · 2010-11-15

ApplicantCianna Medical
Decision Date2010-11-15
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cianna Medical. It received FDA 510(k) clearance on 2010-11-15 under 510(k) number K103215. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT?

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT is a medical device that received FDA 510(k) clearance on 2010-11-15. The listed applicant is Cianna Medical. The 510(k) number is K103215.

When did CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT receive FDA 510(k) clearance?

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT received FDA 510(k) clearance on 2010-11-15, under 510(k) number K103215.

Who is the listed applicant for CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT?

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

What is the FDA product code for CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT?

The FDA product code for CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT is JAQ.

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Other records listing Cianna Medical 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.

K120804CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM

Related Devices (Code: JAQ)

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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