FDA 510(k)

PHARMASEAL DUAL LUMEN CATHETER

K-Number: K861165 · 1986-05-05

Decision Date1986-05-05

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PHARMASEAL DUAL LUMEN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1986-05-05 under 510(k) number K861165. 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 PHARMASEAL DUAL LUMEN CATHETER?

PHARMASEAL DUAL LUMEN CATHETER is a medical device that received FDA 510(k) clearance on 1986-05-05. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K861165.

When did PHARMASEAL DUAL LUMEN CATHETER receive FDA 510(k) clearance?

PHARMASEAL DUAL LUMEN CATHETER received FDA 510(k) clearance on 1986-05-05, under 510(k) number K861165.

Who is the listed applicant for PHARMASEAL DUAL LUMEN CATHETER?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMASEAL DUAL LUMEN CATHETER?

The FDA product code for PHARMASEAL DUAL LUMEN CATHETER is DQY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Pharmaseal Div. Ahsc as applicant

K874022PHARMASEAL WOUND IRRIGATION DEVICE K874517PHARMASEAL RUBBER URETHRAL CATHETER K874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER K873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE K872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM K872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

View all 64 devices →

Related Devices (Code: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.