Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4075](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4075) → DWZ — Device, Biopsy, Endomyocardial # DWZ · Device, Biopsy, Endomyocardial _Cardiovascular · 21 CFR 870.4075 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ ## Overview - **Product Code:** DWZ - **Device Name:** Device, Biopsy, Endomyocardial - **Regulation:** [21 CFR 870.4075](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4075) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K252722.md) | Biopsy Forceps | Fehling Instruments GmbH | Sep 30, 2025 | SESE | | [K170726](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K170726.md) | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | Jun 2, 2017 | SESE | | [K072051](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K072051.md) | NOVATOME, MODEL: SU101-50 | Scholten Surgical Instruments, Inc. | Oct 3, 2007 | SESE | | [K010473](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K010473.md) | SPARROWHAWK DISPOSABLE | Atc Technologies, Inc. | Jun 6, 2001 | SESE | | [K000409](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K000409.md) | MODIFICATION TO T-REX BIOPSY FORCEPS | Boston Scientific Corp | Feb 28, 2000 | SESE | | [K991486](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K991486.md) | ULTRA-CBX | Medcanica, Inc. | Nov 5, 1999 | SESE | | [K974175](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K974175.md) | HEARTPORT ENDOAORTIC CLAMP CATHETER | Heartport, Inc. | Dec 16, 1997 | SESE | | [K973818](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K973818.md) | T-REX BIOPSY FORCEPS | Boston Scientific Corp | Dec 16, 1997 | SESE | | [K951447](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K951447.md) | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | Portlyn Corp. | Jul 27, 1995 | SESE | | [K933235](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K933235.md) | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | Cordis Corp. | Jan 6, 1994 | SESE | | [K932788](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K932788.md) | CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE | Cordis Corp. | Sep 1, 1993 | SESE | | [K921401](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K921401.md) | BIOPSY FORCEPS | Annex Medical, Inc. | Oct 21, 1992 | SESE | | [K920289](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K920289.md) | CORDIS BIPAL 7 BIOPSY FORCEPS | Cordis Corp. | Mar 30, 1992 | SESE | | [K914567](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K914567.md) | CORDIS BIPAL BIOPSY FORCEPS | Cordis Corp. | Dec 18, 1991 | SESE | | [K910840](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K910840.md) | VASCULAR BIOPSY FORCEPS | Vascular Products, Inc. | Jul 15, 1991 | SESE | | [K901300](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K901300.md) | BIOPSY FORCEPS | Portlyn Corp. | Jun 29, 1990 | SESE | | [K895098](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K895098.md) | BIOPSY FORCEPS | Annex Medical, Inc. | Oct 30, 1989 | SESE | | [K890453](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K890453.md) | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | Dlp, Inc. | Mar 31, 1989 | SESE | | [K883723](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K883723.md) | FLEXIBLE MYOCARDIAL BIOPSY FORCEPS | Cook, Inc. | Dec 5, 1988 | SESE | | [K882383](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ/K882383.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com