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FDA 510(k)

SCANLAN SINGLE-USE AORTA PUNCH

K-Number: K823764 · 1983-03-24

ApplicantScanlan Intl., Inc.
Decision Date1983-03-24
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCANLAN SINGLE-USE AORTA PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K823764. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN SINGLE-USE AORTA PUNCH?

SCANLAN SINGLE-USE AORTA PUNCH is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K823764.

When did SCANLAN SINGLE-USE AORTA PUNCH receive FDA 510(k) clearance?

SCANLAN SINGLE-USE AORTA PUNCH received FDA 510(k) clearance on 1983-03-24, under 510(k) number K823764.

Who is the listed applicant for SCANLAN SINGLE-USE AORTA PUNCH?

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

What is the FDA product code for SCANLAN SINGLE-USE AORTA PUNCH?

The FDA product code for SCANLAN SINGLE-USE AORTA PUNCH is DWS.

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Other records listing Scanlan Intl., 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.

K960372SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEMK945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERK911184SCANLAN/TAHERI VALVULOTOMEK864919SCANLAN (TM) VEIN/GRAFT HOLDERK864920SCANLAN (TM) INSTRUMENT TRAYK851825SCANLAN TUNNELER, SHEATH & TIP

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Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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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