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 HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)

K-Number: K883135 · 1988-09-26

ApplicantPioneering Technologies, Inc.
Decision Date1988-09-26
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) 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 1988-09-26 under 510(k) number K883135. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)?

PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) is a medical device that received FDA 510(k) clearance on 1988-09-26. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K883135.

When did PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) receive FDA 510(k) clearance?

PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) received FDA 510(k) clearance on 1988-09-26, under 510(k) number K883135.

Who is the listed applicant for PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)?

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 HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)?

The FDA product code for PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) is DWS.

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 GRAFTK901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS

View all 19 devices →

Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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.

↑