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FDA 510(k)

NEO MAPCATH SENSOR STYLET

K-Number: K083121 · 2009-02-11

ApplicantCorpak Medsystems
Decision Date2009-02-11
Product CodeOMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEO MAPCATH SENSOR STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Medsystems. It received FDA 510(k) clearance on 2009-02-11 under 510(k) number K083121. The device is classified under product code OMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO MAPCATH SENSOR STYLET?

NEO MAPCATH SENSOR STYLET is a medical device that received FDA 510(k) clearance on 2009-02-11. The listed applicant is Corpak Medsystems. The 510(k) number is K083121.

When did NEO MAPCATH SENSOR STYLET receive FDA 510(k) clearance?

NEO MAPCATH SENSOR STYLET received FDA 510(k) clearance on 2009-02-11, under 510(k) number K083121.

Who is the listed applicant for NEO MAPCATH SENSOR STYLET?

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

What is the FDA product code for NEO MAPCATH SENSOR STYLET?

The FDA product code for NEO MAPCATH SENSOR STYLET is OMF.

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Other records listing Corpak Medsystems 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.

K131532ELECTROMAGNETIC TRANSMITTING STYLETK113351CORTRAK ENTERAL ACCESS DEVICEK100365FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIVK091637CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900K083776CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-SK083791CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S

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Related Devices (Code: OMF)

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.

K093510LUMENVU CATHETER GUIDANCE SYSTEMSonosite,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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