Device, Biopsy, Endomyocardial
FDA product code DWZ · Class II (moderate risk) · 21 CFR 870.4075 · Cardiovascular
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Cordis Corp. 5
- Annex Medical, Inc. 2
- Portlyn Corp. 2
- Boston Scientific Corporation 2
- Fehling Instruments GmbH & Co. KG 2
- Mansfield Scientific, Inc. 1
- Fehling Medizintechnik GmbH 1
- CIVCO Medical Instruments Co., Inc. 1
- Cook, Inc. 1
- Dlp, Inc. 1
- Vascular Products, Inc. 1
- Heartport, Inc. 1
- Medcanica, Inc. 1
- Atc Technologies, Inc. 1
- Scholten Surgical Instruments, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252722 | Biopsy ForcepsDWZ · Special | Fehling Instruments GmbH | 09/30/2025SE |
| K170726 | Biopsy ForcepsDWZ · Traditional | Fehling Instruments GmbH & Co. KG | 06/02/2017SE |
| K072051 | Novatome, Model: SU101-50DWZ · Traditional | Scholten Surgical Instruments, Inc. | 10/03/2007SE |
| K010473 | Sparrowhawk DisposableDWZ · Traditional | Atc Technologies, Inc. | 06/06/2001SE |
| K000409 | Modification to T-Rex Biopsy ForcepsDWZ · Special | Boston Scientific Corp | 02/28/2000SE |
| K991486 | Ultra-CbxDWZ · Traditional | Medcanica, Inc. | 11/05/1999SE |
| K974175 | Heartport Endoaortic Clamp CatheterDWZ · Traditional | Heartport, Inc. | 12/16/1997SE |
| K973818 | T-Rex Biopsy ForcepsDWZ · Traditional | Boston Scientific Corp | 12/16/1997SE |
| K951447 | Dynabite Cardiovascular Biopsy ForcepsDWZ · Traditional | Portlyn Corp. | 07/27/1995SE |
| K933235 | Cordis Bipal 7 /Biopsy & Bipal Biopsy Forceps, ModifDWZ · Traditional | Cordis Corp. | 01/06/1994SE |
| K932788 | Cordis Bipal 7 Biopsy Forceps with a Inline HandleDWZ · Traditional | Cordis Corp. | 09/01/1993SE |
| K921401 | Biopsy ForcepsDWZ · Traditional | Annex Medical, Inc. | 10/21/1992SE |
| K920289 | Cordis Bipal 7 Biopsy ForcepsDWZ · Traditional | Cordis Corp. | 03/30/1992SE |
| K914567 | Cordis Bipal Biopsy ForcepsDWZ · Traditional | Cordis Corp. | 12/18/1991SE |
| K910840 | Vascular Biopsy ForcepsDWZ · Traditional | Vascular Products, Inc. | 07/15/1991SE |
| K901300 | Biopsy ForcepsDWZ · Traditional | Portlyn Corp. | 06/29/1990SE |
| K895098 | Biopsy ForcepsDWZ · Traditional | Annex Medical, Inc. | 10/30/1989SE |
| K890453 | Reusable Mlyocardial Biopsy Forceps (BioptomesDWZ · Traditional | Dlp, Inc. | 03/31/1989SE |
| K883723 | Flexible Myocardial Biopsy ForcepsDWZ · Traditional | Cook, Inc. | 12/05/1988SE |
| K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter GuidesDWZ · Traditional | CIVCO Medical Instruments Co., Inc. | 11/28/1988SE |
| K881412 | Myocard Biopsy ForcepDWZ · Traditional | Fehling Medizintechnik GmbH | 09/08/1988SE |
| K870186 | Endomyocardial Biopsy DeviceDWZ · Traditional | Mansfield Scientific, Inc. | 02/20/1987SE |
| K810849 | Cordis Biopsy ForcepsDWZ · Traditional | Cordis Corp. | 04/17/1981SE |