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FDA 510(k)

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

K-Number: K013029 · 2001-10-09

ApplicantSt Jude Medical
Decision Date2001-10-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 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 2001-10-09 under 510(k) number K013029. 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 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515?

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is St Jude Medical. The 510(k) number is K013029.

When did SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 receive FDA 510(k) clearance?

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 received FDA 510(k) clearance on 2001-10-09, under 510(k) number K013029.

Who is the listed applicant for SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515?

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 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515?

The FDA product code for SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 is DYB.

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Related Devices (Code: 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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