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FDA 510(k)

DILATOR, VESSEL & INTRODUCER, SHEATH

K-Number: K780126 · 1978-03-02

ApplicantArgon Medical Corp.
Decision Date1978-03-02
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DILATOR, VESSEL & INTRODUCER, SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Corp.. It received FDA 510(k) clearance on 1978-03-02 under 510(k) number K780126. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILATOR, VESSEL & INTRODUCER, SHEATH?

DILATOR, VESSEL & INTRODUCER, SHEATH is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Argon Medical Corp.. The 510(k) number is K780126.

When did DILATOR, VESSEL & INTRODUCER, SHEATH receive FDA 510(k) clearance?

DILATOR, VESSEL & INTRODUCER, SHEATH received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780126.

Who is the listed applicant for DILATOR, VESSEL & INTRODUCER, SHEATH?

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

What is the FDA product code for DILATOR, VESSEL & INTRODUCER, SHEATH?

The FDA product code for DILATOR, VESSEL & INTRODUCER, SHEATH is DRE.

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Other records listing Argon Medical Corp. 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.

K904994CLOSED SYSTEM FLUSH SETK895511CATHETER BALLOON DILATOR PRESSURE GAUGEK894157OBTURATORK891022INTRODUCER FOR PTCA GUIDING CATHETERSK884375TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETERK882221OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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