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)

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT

K-Number: K894684 · 1989-10-17

ApplicantPioneering Technologies, Inc.
Decision Date1989-10-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pioneering Technologies, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K894684. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT?

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K894684.

When did PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT receive FDA 510(k) clearance?

PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT received FDA 510(k) clearance on 1989-10-17, under 510(k) number K894684.

Who is the listed applicant for PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT?

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

What is the FDA product code for PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT?

The FDA product code for PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT is DWF.

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 Pioneering Technologies, 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.

K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIFK905175PTI ANNULOPLASTY RING(STERILE)K905068PTI INTRA-ART (TM) PICK-UP WICKSK910067PTI STERNAL CLOSURE WIRE SUTUREK905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTK901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

View all 19 devices →

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.

↑