Who is the manufacturer of BIOPSY FORCEPS?

Portlyn Corp. filed the 510(k) submission for BIOPSY FORCEPS (K901300).

What is the FDA product code for BIOPSY FORCEPS?

DWZ. It is classified under 21 CFR 870.4075 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BIOPSY FORCEPS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BIOPSY FORCEPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOPSY FORCEPS

K901300 · Portlyn Corp. · DWZ · Jun 29, 1990 · Cardiovascular

Device Facts

Record ID	K901300
Device Name	BIOPSY FORCEPS
Applicant	Portlyn Corp.
Product Code	DWZ · Cardiovascular
Decision Date	Jun 29, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4075
Device Class	Class 2

Regulatory Classification

Identification

An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

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