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)

AUTOWAND(TM) 7XXX SERIES, MODIFICATION

K-Number: K904888 · 1991-01-16

ApplicantBoehringer Laboratories
Decision Date1991-01-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOWAND(TM) 7XXX SERIES, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K904888. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOWAND(TM) 7XXX SERIES, MODIFICATION?

AUTOWAND(TM) 7XXX SERIES, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Boehringer Laboratories. The 510(k) number is K904888.

When did AUTOWAND(TM) 7XXX SERIES, MODIFICATION receive FDA 510(k) clearance?

AUTOWAND(TM) 7XXX SERIES, MODIFICATION received FDA 510(k) clearance on 1991-01-16, under 510(k) number K904888.

Who is the listed applicant for AUTOWAND(TM) 7XXX SERIES, MODIFICATION?

The FDA 510(k) record lists Boehringer Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOWAND(TM) 7XXX SERIES, MODIFICATION?

The FDA product code for AUTOWAND(TM) 7XXX SERIES, MODIFICATION is CAC.

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 Boehringer Laboratories 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.

K234145ViSiGi 3D Gastric Sizing TubeK061788BOEHRINGER LABORATORIES SUCTION PUMP SYSTEMK060277BOEHRINGER LABORATORIES SUCTION PUMP SYSTEMK020538BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIESK014187AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEMK013976BOEHRINGER MRI SUCTION REGULATORY

View all 38 devices →

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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.

↑