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FDA 510(k)

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500

K-Number: K070893 · 2007-05-01

ApplicantCSA Medical, Inc.
Decision Date2007-05-01
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 is the device name listed in this FDA 510(k) record. The listed applicant is CSA Medical, Inc.. It received FDA 510(k) clearance on 2007-05-01 under 510(k) number K070893. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500?

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 is a medical device that received FDA 510(k) clearance on 2007-05-01. The listed applicant is CSA Medical, Inc.. The 510(k) number is K070893.

When did CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 receive FDA 510(k) clearance?

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 received FDA 510(k) clearance on 2007-05-01, under 510(k) number K070893.

Who is the listed applicant for CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500?

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

What is the FDA product code for CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500?

The FDA product code for CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 is GEH.

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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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