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FDA 510(k)

Arrow Stiffening Stylet

K-Number: K220280 · 2022-08-30

ApplicantArrow International, LLC (A subsidiary of Teleflex, Inc.)
Decision Date2022-08-30
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arrow Stiffening Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K220280. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arrow Stiffening Stylet?

Arrow Stiffening Stylet is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220280.

When did Arrow Stiffening Stylet receive FDA 510(k) clearance?

Arrow Stiffening Stylet received FDA 510(k) clearance on 2022-08-30, under 510(k) number K220280.

Who is the listed applicant for Arrow Stiffening Stylet?

The FDA 510(k) record lists Arrow International, LLC (A subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arrow Stiffening Stylet?

The FDA product code for Arrow Stiffening Stylet is DRB.

Other records listing Arrow International, LLC (A subsidiary of Teleflex, 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.

K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)K220363VPS Rhythm DLX Device with TipTracker Technology

Related Devices (Code: DRB)

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.

K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook Incorporated

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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