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)

Sublime Microcatheter

K-Number: K221886 · 2022-10-14

ApplicantSurmodics,Inc.
Decision Date2022-10-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sublime Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221886. 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 Sublime Microcatheter?

Sublime Microcatheter is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Surmodics,Inc.. The 510(k) number is K221886.

When did Sublime Microcatheter receive FDA 510(k) clearance?

Sublime Microcatheter received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221886.

Who is the listed applicant for Sublime Microcatheter?

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

What is the FDA product code for Sublime Microcatheter?

The FDA product code for Sublime Microcatheter is DQY.

Other records listing Surmodics,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.

K252227Pounce(TM) SheathPMA P210025Drug-Eluting Peripheral Transluminal Angioplasty CatheterK241362Pounce XL Thrombectomy System (PTS-1011-7F135)K232647MicrocatheterK231828Pounce™ SheathK231022Pounce™ Thrombectomy System

View all 12 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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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.

↑