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)

POLYETHYLENE TEREPHTHALATE (PET) PLEDGET

K-Number: K953425 · 1995-08-21

ApplicantDavis & Geck, Inc.
Decision Date1995-08-21
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYETHYLENE TEREPHTHALATE (PET) PLEDGET is the device name listed in this FDA 510(k) record. The listed applicant is Davis & Geck, Inc.. It received FDA 510(k) clearance on 1995-08-21 under 510(k) number K953425. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYETHYLENE TEREPHTHALATE (PET) PLEDGET?

POLYETHYLENE TEREPHTHALATE (PET) PLEDGET is a medical device that received FDA 510(k) clearance on 1995-08-21. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K953425.

When did POLYETHYLENE TEREPHTHALATE (PET) PLEDGET receive FDA 510(k) clearance?

POLYETHYLENE TEREPHTHALATE (PET) PLEDGET received FDA 510(k) clearance on 1995-08-21, under 510(k) number K953425.

Who is the listed applicant for POLYETHYLENE TEREPHTHALATE (PET) PLEDGET?

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

What is the FDA product code for POLYETHYLENE TEREPHTHALATE (PET) PLEDGET?

The FDA product code for POLYETHYLENE TEREPHTHALATE (PET) PLEDGET is DXZ.

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 Davis & Geck, 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.

K982853SILK SUTUREK981582SURGILON, DERMALON, & OPHTHALONK974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRALK980610DEXON RAPID (DEXON R)K980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICEK973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS

View all 45 devices →

Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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.

↑