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)

SIGNATURE(TM) CUSTOM TUBING PACK

K-Number: K924529 · 1993-06-23

ApplicantAvecor Cardiovascular, Inc.
Decision Date1993-06-23
Product CodeDWF
Advisory CommitteeCV
DecisionUnknown

Device Summary

SIGNATURE(TM) CUSTOM TUBING PACK is the device name listed in this FDA 510(k) record. The listed applicant is Avecor Cardiovascular, Inc.. It received FDA 510(k) clearance on 1993-06-23 under 510(k) number K924529. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SIGNATURE(TM) CUSTOM TUBING PACK?

SIGNATURE(TM) CUSTOM TUBING PACK is a medical device that received FDA 510(k) clearance on 1993-06-23. The listed applicant is Avecor Cardiovascular, Inc.. The 510(k) number is K924529.

When did SIGNATURE(TM) CUSTOM TUBING PACK receive FDA 510(k) clearance?

SIGNATURE(TM) CUSTOM TUBING PACK received FDA 510(k) clearance on 1993-06-23, under 510(k) number K924529.

Who is the listed applicant for SIGNATURE(TM) CUSTOM TUBING PACK?

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

What is the FDA product code for SIGNATURE(TM) CUSTOM TUBING PACK?

The FDA product code for SIGNATURE(TM) CUSTOM TUBING PACK 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 Avecor Cardiovascular, 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.

K973760AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACEK964017AFFINITY BLOOD PUMP SYSTEMK971105MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEMK952532AFFINITY ARTERIAL BLOOD FILTERK940126AVECOR PRE-BYPASS FILTERK936003AFFINITY CVR

View all 9 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.

↑