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FDA 510(k)

DILATOR, VESSEL, FOR PERC. CATHETER.

K-Number: K801113 · 1980-07-28

ApplicantAlva Medical, Inc.
Decision Date1980-07-28
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DILATOR, VESSEL, FOR PERC. CATHETER. is the device name listed in this FDA 510(k) record. The listed applicant is Alva Medical, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801113. 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, FOR PERC. CATHETER.?

DILATOR, VESSEL, FOR PERC. CATHETER. is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Alva Medical, Inc.. The 510(k) number is K801113.

When did DILATOR, VESSEL, FOR PERC. CATHETER. receive FDA 510(k) clearance?

DILATOR, VESSEL, FOR PERC. CATHETER. received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801113.

Who is the listed applicant for DILATOR, VESSEL, FOR PERC. CATHETER.?

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

What is the FDA product code for DILATOR, VESSEL, FOR PERC. CATHETER.?

The FDA product code for DILATOR, VESSEL, FOR PERC. CATHETER. is DRE.

Related Clinical Trials

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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Other records listing Alva Medical, 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.

K800580PERCUTANEOUS CATHETER INTRODUCER

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

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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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