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FDA 510(k)

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

K-Number: K113235 · 2011-12-02

ApplicantMedtronic, Inc.
Decision Date2011-12-02
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2011-12-02 under 510(k) number K113235. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS?

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS is a medical device that received FDA 510(k) clearance on 2011-12-02. The listed applicant is Medtronic, Inc.. The 510(k) number is K113235.

When did PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS receive FDA 510(k) clearance?

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS received FDA 510(k) clearance on 2011-12-02, under 510(k) number K113235.

Who is the listed applicant for PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS?

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

What is the FDA product code for PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS?

The FDA product code for PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS is DXS.

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Related Devices (Code: DXS)

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.

K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology IncorporatedK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.K873802PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, Inc.K852232PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, 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.

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