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FDA 510(k)

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S

K-Number: K073100 · 2007-11-30

ApplicantOscor, Inc.
Decision Date2007-11-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2007-11-30 under 510(k) number K073100. 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 INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S?

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S is a medical device that received FDA 510(k) clearance on 2007-11-30. The listed applicant is Oscor, Inc.. The 510(k) number is K073100.

When did INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S receive FDA 510(k) clearance?

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S received FDA 510(k) clearance on 2007-11-30, under 510(k) number K073100.

Who is the listed applicant for INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S?

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

What is the FDA product code for INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S?

The FDA product code for INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S is DYB.

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Other records listing Oscor, Inc. as applicant

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Related Devices (Code: DYB)

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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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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