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FDA 510(k)

PERFORMER CBP SYSTEM

K-Number: K070213 · 2007-03-21

ApplicantRand S.R.L.
Decision Date2007-03-21
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERFORMER CBP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2007-03-21 under 510(k) number K070213. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFORMER CBP SYSTEM?

PERFORMER CBP SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-21. The listed applicant is Rand S.R.L.. The 510(k) number is K070213.

When did PERFORMER CBP SYSTEM receive FDA 510(k) clearance?

PERFORMER CBP SYSTEM received FDA 510(k) clearance on 2007-03-21, under 510(k) number K070213.

Who is the listed applicant for PERFORMER CBP SYSTEM?

The FDA 510(k) record lists Rand S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFORMER CBP SYSTEM?

The FDA product code for PERFORMER CBP SYSTEM is DTQ.

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.

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Other records listing Rand S.R.L. 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.

K161613Hang&Go PACK120026PERFORMER HT/ HANG&GO HT BASICK052555MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB

Related Devices (Code: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

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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