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FDA 510(k)

B7 2C Occlusion Balloon

K-Number: K171492 · 2017-11-20

ApplicantSpiration, Inc.
Decision Date2017-11-20
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

B7 2C Occlusion Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Spiration, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K171492. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B7 2C Occlusion Balloon?

B7 2C Occlusion Balloon is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Spiration, Inc.. The 510(k) number is K171492.

When did B7 2C Occlusion Balloon receive FDA 510(k) clearance?

B7 2C Occlusion Balloon received FDA 510(k) clearance on 2017-11-20, under 510(k) number K171492.

Who is the listed applicant for B7 2C Occlusion Balloon?

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

What is the FDA product code for B7 2C Occlusion Balloon?

The FDA product code for B7 2C Occlusion Balloon is EOQ.

Other records listing Spiration, 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.

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Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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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