DWZ · Device, Biopsy, Endomyocardial
Cardiovascular · 21 CFR 870.4075 · Class 2
Overview
| Product Code | DWZ |
|---|---|
| Device Name | Device, Biopsy, Endomyocardial |
| Regulation | 21 CFR 870.4075 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252722 | Biopsy Forceps | Fehling Instruments GmbH | Sep 30, 2025 | SESE |
| K170726 | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | Jun 2, 2017 | SESE |
| K072051 | NOVATOME, MODEL: SU101-50 | Scholten Surgical Instruments, Inc. | Oct 3, 2007 | SESE |
| K010473 | SPARROWHAWK DISPOSABLE | Atc Technologies, Inc. | Jun 6, 2001 | SESE |
| K000409 | MODIFICATION TO T-REX BIOPSY FORCEPS | Boston Scientific Corp | Feb 28, 2000 | SESE |
| K991486 | ULTRA-CBX | Medcanica, Inc. | Nov 5, 1999 | SESE |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | Heartport, Inc. | Dec 16, 1997 | SESE |
| K973818 | T-REX BIOPSY FORCEPS | Boston Scientific Corp | Dec 16, 1997 | SESE |
| K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | Portlyn Corp. | Jul 27, 1995 | SESE |
| K933235 | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | Cordis Corp. | Jan 6, 1994 | SESE |
| K932788 | CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE | Cordis Corp. | Sep 1, 1993 | SESE |
| K921401 | BIOPSY FORCEPS | Annex Medical, Inc. | Oct 21, 1992 | SESE |
| K920289 | CORDIS BIPAL 7 BIOPSY FORCEPS | Cordis Corp. | Mar 30, 1992 | SESE |
| K914567 | CORDIS BIPAL BIOPSY FORCEPS | Cordis Corp. | Dec 18, 1991 | SESE |
| K910840 | VASCULAR BIOPSY FORCEPS | Vascular Products, Inc. | Jul 15, 1991 | SESE |
| K901300 | BIOPSY FORCEPS | Portlyn Corp. | Jun 29, 1990 | SESE |
| K895098 | BIOPSY FORCEPS | Annex Medical, Inc. | Oct 30, 1989 | SESE |
| K890453 | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | Dlp, Inc. | Mar 31, 1989 | SESE |
| K883723 | FLEXIBLE MYOCARDIAL BIOPSY FORCEPS | Cook, Inc. | Dec 5, 1988 | SESE |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | CIVCO Medical Instruments Co., Inc. | Nov 28, 1988 | SESE |
Top Applicants
- Cordis Corp. — 5 clearances
- Portlyn Corp. — 2 clearances
- Boston Scientific Corp — 2 clearances
- Annex Medical, Inc. — 2 clearances
- Vascular Products, Inc. — 1 clearance
