FDA 510(k)

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

K-Number: K940425 · 1994-08-01

Decision Date1994-08-01

Product CodeMAV

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1994-08-01 under 510(k) number K940425. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING?

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING is a medical device that received FDA 510(k) clearance on 1994-08-01. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K940425.

When did IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING receive FDA 510(k) clearance?

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING received FDA 510(k) clearance on 1994-08-01, under 510(k) number K940425.

Who is the listed applicant for IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING?

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

What is the FDA product code for IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING?

The FDA product code for IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING is MAV.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Imagyn Medical, Inc. as applicant

K972426MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH K970750MICROSPAN INSEMINATION SYSTEM K971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER K965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES K963580IMAGYN FALLOPOSCOPY SYSTEM K961688MICROSPAN HYSTEROSCOPE

View all 19 devices →

Related Devices (Code: MAV)

K260035Digital Indeflator INFLANTEUAB Telemedicina K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic Vascular K162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, 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.