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FDA 510(k)

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)

K-Number: K870413 · 1987-06-01

ApplicantMedical Surgical Concepts, Inc.
Decision Date1987-06-01
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Surgical Concepts, Inc.. It received FDA 510(k) clearance on 1987-06-01 under 510(k) number K870413. 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 PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)?

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) is a medical device that received FDA 510(k) clearance on 1987-06-01. The listed applicant is Medical Surgical Concepts, Inc.. The 510(k) number is K870413.

When did PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) receive FDA 510(k) clearance?

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) received FDA 510(k) clearance on 1987-06-01, under 510(k) number K870413.

Who is the listed applicant for PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)?

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

What is the FDA product code for PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)?

The FDA product code for PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) 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 Medical Surgical Concepts, 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.

K870411CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.K870412TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT

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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