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FDA 510(k)

MEGA PERICARDIOCENTESIS KIT

K-Number: K912564 · 1991-09-05

ApplicantMega Medical, Inc.
Decision Date1991-09-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEGA PERICARDIOCENTESIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mega Medical, Inc.. It received FDA 510(k) clearance on 1991-09-05 under 510(k) number K912564. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGA PERICARDIOCENTESIS KIT?

MEGA PERICARDIOCENTESIS KIT is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is Mega Medical, Inc.. The 510(k) number is K912564.

When did MEGA PERICARDIOCENTESIS KIT receive FDA 510(k) clearance?

MEGA PERICARDIOCENTESIS KIT received FDA 510(k) clearance on 1991-09-05, under 510(k) number K912564.

Who is the listed applicant for MEGA PERICARDIOCENTESIS KIT?

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

What is the FDA product code for MEGA PERICARDIOCENTESIS KIT?

The FDA product code for MEGA PERICARDIOCENTESIS KIT is DQY.

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Other records listing Mega Medical, 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.

K915863MEGA AMNIOCENTESIS KITK913317MEGA ARTHROGRAM KITK913397MEGA ANGIOGRAM KITK912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KITK913382MEGA PARACENTESIS KITK912322MEGA SPINAL ANESTHESIA KIT

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

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