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)

GUIDANT RETRIEVER DEVICE

K-Number: K001694 · 2001-05-15

ApplicantGuidant Cardiac and Vascular Surgery
Decision Date2001-05-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDANT RETRIEVER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Cardiac and Vascular Surgery. It received FDA 510(k) clearance on 2001-05-15 under 510(k) number K001694. 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 GUIDANT RETRIEVER DEVICE?

GUIDANT RETRIEVER DEVICE is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K001694.

When did GUIDANT RETRIEVER DEVICE receive FDA 510(k) clearance?

GUIDANT RETRIEVER DEVICE received FDA 510(k) clearance on 2001-05-15, under 510(k) number K001694.

Who is the listed applicant for GUIDANT RETRIEVER DEVICE?

The FDA 510(k) record lists Guidant Cardiac and Vascular Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUIDANT RETRIEVER DEVICE?

The FDA product code for GUIDANT RETRIEVER DEVICE 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Guidant Cardiac and Vascular Surgery 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.

K003889ANCURE SHEATH MODEL # 40315, 40320, 40325K003495ANCURE LLIAC BALLOON CATHETERK002676ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCERK970470EVT EXPANDABLE SHEATHK970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERK970608EVT MARKER BOARD

View all 7 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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.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 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.

↑