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FDA 510(k)

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT

K-Number: K925608 · 1993-06-16

ApplicantScimed Life Systems, Inc.
Decision Date1993-06-16
Product CodeMFY
Advisory CommitteeCV
DecisionUnknown

Device Summary

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1993-06-16 under 510(k) number K925608. The device is classified under product code MFY. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT?

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT is a medical device that received FDA 510(k) clearance on 1993-06-16. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K925608.

When did SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT receive FDA 510(k) clearance?

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT received FDA 510(k) clearance on 1993-06-16, under 510(k) number K925608.

Who is the listed applicant for SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT?

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

What is the FDA product code for SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT?

The FDA product code for SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT is MFY.

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Other records listing Scimed Life Systems, Inc. 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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