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)

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

K-Number: K914489 · 1992-08-17

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1992-08-17
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics Pacing Systems, Inc.. It received FDA 510(k) clearance on 1992-08-17 under 510(k) number K914489. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING?

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING is a medical device that received FDA 510(k) clearance on 1992-08-17. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K914489.

When did NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING receive FDA 510(k) clearance?

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING received FDA 510(k) clearance on 1992-08-17, under 510(k) number K914489.

Who is the listed applicant for NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING?

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

What is the FDA product code for NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING?

The FDA product code for NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING is DTB.

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 Telectronics Pacing Systems, 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.

K961118MAXIM PF MODELS 033-581/033-590K943657STERILIZATIONK934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MMK926340NEW LEAD INTRODUCER KITS, VARIOUS MODELSK913919UNIVERSAL TERMINAL CAP, 3.2MMK912773UNIPOLAR UPSIZING ADAPTOR

View all 20 devices →

Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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.

↑