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)

MODEL SP5800 #8 FRENCH INTRO. KIT

K-Number: K823262 · 1983-01-18

ApplicantGould, Inc.
Decision Date1983-01-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SP5800 #8 FRENCH INTRO. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1983-01-18 under 510(k) number K823262. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL SP5800 #8 FRENCH INTRO. KIT?

MODEL SP5800 #8 FRENCH INTRO. KIT is a medical device that received FDA 510(k) clearance on 1983-01-18. The listed applicant is Gould, Inc.. The 510(k) number is K823262.

When did MODEL SP5800 #8 FRENCH INTRO. KIT receive FDA 510(k) clearance?

MODEL SP5800 #8 FRENCH INTRO. KIT received FDA 510(k) clearance on 1983-01-18, under 510(k) number K823262.

Who is the listed applicant for MODEL SP5800 #8 FRENCH INTRO. KIT?

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

What is the FDA product code for MODEL SP5800 #8 FRENCH INTRO. KIT?

The FDA product code for MODEL SP5800 #8 FRENCH INTRO. KIT is DYB.

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 Gould, 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

View all 31 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑