Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ASAHI CROSSWALK Peripheral Support Catheter

K-Number: K192782 · 2019-11-29

Decision Date2019-11-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI CROSSWALK Peripheral Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2019-11-29 under 510(k) number K192782. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI CROSSWALK Peripheral Support Catheter?

ASAHI CROSSWALK Peripheral Support Catheter is a medical device that received FDA 510(k) clearance on 2019-11-29. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K192782.

When did ASAHI CROSSWALK Peripheral Support Catheter receive FDA 510(k) clearance?

ASAHI CROSSWALK Peripheral Support Catheter received FDA 510(k) clearance on 2019-11-29, under 510(k) number K192782.

Who is the listed applicant for ASAHI CROSSWALK Peripheral Support Catheter?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI CROSSWALK Peripheral Support Catheter?

The FDA product code for ASAHI CROSSWALK Peripheral Support Catheter is DQY.

Other records listing Asahi Intecc Co., Ltd. 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.

View all 45 devices →

Related Devices (Code: DQY)

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.

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.