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FDA 510(k)

SCANLAN VASCU-STATT II

K-Number: K841515 · 1984-06-05

ApplicantScanlan Intl., Inc.
Decision Date1984-06-05
Product CodeHRG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCANLAN VASCU-STATT II 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 1984-06-05 under 510(k) number K841515. The device is classified under product code HRG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN VASCU-STATT II?

SCANLAN VASCU-STATT II is a medical device that received FDA 510(k) clearance on 1984-06-05. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K841515.

When did SCANLAN VASCU-STATT II receive FDA 510(k) clearance?

SCANLAN VASCU-STATT II received FDA 510(k) clearance on 1984-06-05, under 510(k) number K841515.

Who is the listed applicant for SCANLAN VASCU-STATT II?

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 VASCU-STATT II?

The FDA product code for SCANLAN VASCU-STATT II is HRG.

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Other records listing Scanlan Intl., Inc. as applicant

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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: HRG)

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.

K013151ASMOTOM AUTOMATED TREPHINE SYSTEMBkg Opthalmics USA, Inc.K981063AUTOMATED CORNEAL TREPHINELaser Center Dev. Corp.K843957ULTRATHIN/SP LENSOptical Systems Intl., Inc.K823901TREPHINE BLADES-VARIOUS MODELSEdward Weck, Inc.K791763(MICRO-KERATRON, MICRO DUCT TREPHINE)Intl. Ophthalmic Industries Corp.

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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