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)

MODIFICATION OF TISSUE DILATOR

K-Number: K862288 · 1986-08-19

ApplicantQuinton, Inc.
Decision Date1986-08-19
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF TISSUE DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862288. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF TISSUE DILATOR?

MODIFICATION OF TISSUE DILATOR is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Quinton, Inc.. The 510(k) number is K862288.

When did MODIFICATION OF TISSUE DILATOR receive FDA 510(k) clearance?

MODIFICATION OF TISSUE DILATOR received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862288.

Who is the listed applicant for MODIFICATION OF TISSUE DILATOR?

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

What is the FDA product code for MODIFICATION OF TISSUE DILATOR?

The FDA product code for MODIFICATION OF TISSUE DILATOR is DRE.

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 Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

View all 164 devices →

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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.

↑