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FDA 510(k)

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984

K-Number: K070417 · 2007-06-05

ApplicantSt Jude Medical
Decision Date2007-06-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2007-06-05 under 510(k) number K070417. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984?

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 is a medical device that received FDA 510(k) clearance on 2007-06-05. The listed applicant is St Jude Medical. The 510(k) number is K070417.

When did ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 receive FDA 510(k) clearance?

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 received FDA 510(k) clearance on 2007-06-05, under 510(k) number K070417.

Who is the listed applicant for ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984?

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

What is the FDA product code for ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984?

The FDA product code for ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 is DYB.

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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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