Product Code: DWZ FDA class 2 21 CFR 870.4075

Device, Biopsy, Endomyocardial

Cardiovascular

The Endomyocardial Biopsy Device is a cardiovascular instrument used to obtain small samples of heart muscle tissue via a catheter introduced into the heart, enabling histological diagnosis of myocarditis, cardiomyopathy, or transplant rejection. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWZ and it is regulated under 21 CFR 870.4075 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: DWZ
Device Class: FDA class 2
Regulation Number: 870.4075
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252722	Biopsy Forceps	Sep 30, 2025	Substantially Equivalent	Fehling Instruments GmbH
K170726	Biopsy Forceps	Jun 02, 2017	Substantially Equivalent	Fehling Instruments GmbH & Co. KG
K072051	NOVATOME, MODEL: SU101-50	Oct 03, 2007	Substantially Equivalent	Scholten Surgical Instruments, Inc.
K010473	SPARROWHAWK DISPOSABLE	Jun 06, 2001	Substantially Equivalent	Atc Technologies, Inc.
K000409	MODIFICATION TO T-REX BIOPSY FORCEPS	Feb 28, 2000	Substantially Equivalent	Boston Scientific Corp
K991486	ULTRA-CBX	Nov 05, 1999	Substantially Equivalent	Medcanica, Inc.
K974175	HEARTPORT ENDOAORTIC CLAMP CATHETER	Dec 16, 1997	Substantially Equivalent	Heartport, Inc.
K973818	T-REX BIOPSY FORCEPS	Dec 16, 1997	Substantially Equivalent	Boston Scientific Corp
K951447	DYNABITE CARDIOVASCULAR BIOPSY FORCEPS	Jul 27, 1995	Substantially Equivalent	Portlyn Corp.
K933235	CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF	Jan 06, 1994	Substantially Equivalent	Cordis Corp.
K932788	CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE	Sep 01, 1993	Substantially Equivalent	Cordis Corp.
K921401	BIOPSY FORCEPS	Oct 21, 1992	Substantially Equivalent	Annex Medical, Inc.
K920289	CORDIS BIPAL 7 BIOPSY FORCEPS	Mar 30, 1992	Substantially Equivalent	Cordis Corp.
K914567	CORDIS BIPAL BIOPSY FORCEPS	Dec 18, 1991	Substantially Equivalent	Cordis Corp.
K910840	VASCULAR BIOPSY FORCEPS	Jul 15, 1991	Substantially Equivalent	Vascular Products, Inc.
K901300	BIOPSY FORCEPS	Jun 29, 1990	Substantially Equivalent	Portlyn Corp.
K895098	BIOPSY FORCEPS	Oct 30, 1989	Substantially Equivalent	Annex Medical, Inc.
K890453	REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES	Mar 31, 1989	Substantially Equivalent	Dlp, Inc.
K883723	FLEXIBLE MYOCARDIAL BIOPSY FORCEPS	Dec 05, 1988	Substantially Equivalent	Cook, Inc.
K882383	MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES	Nov 28, 1988	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.
K881412	MYOCARD BIOPSY FORCEP	Sep 08, 1988	Substantially Equivalent	Fehling Medizintechnik GmbH
K870186	ENDOMYOCARDIAL BIOPSY DEVICE	Feb 20, 1987	Substantially Equivalent	Mansfield Scientific, Inc.
K810849	CORDIS BIOPSY FORCEPS	Apr 17, 1981	Substantially Equivalent	Cordis Corp.