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)

REGULATED PRESSURE INJECTOR

K-Number: K860806 · 1986-03-31

ApplicantTarget Therapeutics
Decision Date1986-03-31
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REGULATED PRESSURE INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860806. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGULATED PRESSURE INJECTOR?

REGULATED PRESSURE INJECTOR is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Target Therapeutics. The 510(k) number is K860806.

When did REGULATED PRESSURE INJECTOR receive FDA 510(k) clearance?

REGULATED PRESSURE INJECTOR received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860806.

Who is the listed applicant for REGULATED PRESSURE INJECTOR?

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

What is the FDA product code for REGULATED PRESSURE INJECTOR?

The FDA product code for REGULATED PRESSURE INJECTOR is DXF.

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 Target Therapeutics 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.

K965071DETACHABLE SLICONE BALLOON (DSB)K964488DETACHABLE SILICONE BALLOON (DSB)K964210RETRIEVER IIK971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCEK965189SPINNAKERK964112BERENSTEIN COIL

View all 70 devices →

Related Devices (Code: DXF)

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.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, 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.

↑