Product code DWZ
- Device name
- Device, Biopsy, Endomyocardial
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4075
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252722 | Biopsy Forceps | Fehling Instruments GmbH | 2025-09-30 |
| K170726 | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | 2017-06-02 |
| K072051 | NOVATOME, MODEL: SU101-50 | Scholten Surgical Instruments, Inc. | 2007-10-03 |
| K010473 | SPARROWHAWK DISPOSABLE | Atc Technologies, Inc. | 2001-06-06 |
| K000409 | MODIFICATION TO T-REX BIOPSY FORCEPS | Boston Scientific Corp | 2000-02-28 |
| K991486 | ULTRA-CBX | Medcanica, Inc. | 1999-11-05 |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | Heartport, Inc. | 1997-12-16 |
| K973818 | T-REX BIOPSY FORCEPS | Boston Scientific Corp | 1997-12-16 |
| K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | Portlyn Corp. | 1995-07-27 |
| K933235 | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | Cordis Corp. | 1994-01-06 |
| K932788 | CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE | Cordis Corp. | 1993-09-01 |
| K921401 | BIOPSY FORCEPS | Annex Medical, Inc. | 1992-10-21 |
| K920289 | CORDIS BIPAL 7 BIOPSY FORCEPS | Cordis Corp. | 1992-03-30 |
| K914567 | CORDIS BIPAL BIOPSY FORCEPS | Cordis Corp. | 1991-12-18 |
| K910840 | VASCULAR BIOPSY FORCEPS | Vascular Products, Inc. | 1991-07-15 |
| K901300 | BIOPSY FORCEPS | Portlyn Corp. | 1990-06-29 |
| K895098 | BIOPSY FORCEPS | Annex Medical, Inc. | 1989-10-30 |
| K890453 | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | Dlp, Inc. | 1989-03-31 |
| K883723 | FLEXIBLE MYOCARDIAL BIOPSY FORCEPS | Cook, Inc. | 1988-12-05 |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | CIVCO Medical Instruments Co., Inc. | 1988-11-28 |
| K881412 | MYOCARD BIOPSY FORCEP | Fehling Medizintechnik GmbH | 1988-09-08 |
| K870186 | ENDOMYOCARDIAL BIOPSY DEVICE | Mansfield Scientific, Inc. | 1987-02-20 |
| K810849 | CORDIS BIOPSY FORCEPS | Cordis Corp. | 1981-04-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450392843 | Novatome™ | Merit Medical Systems, Inc. | 2026-02-18 |
| 00884450392829 | Novatome™ | Merit Medical Systems, Inc. | 2026-02-18 |
| 00884450392799 | Novatome™ | Merit Medical Systems, Inc. | 2026-02-14 |
| 10705032056120 | BIOPSY FORCEPS STD | Cordis US Corp. | 2024-02-23 |
| 10705032056106 | Biopsy Forceps | Cordis US Corp. | 2021-01-26 |
| 10705032056113 | Biopsy Forceps | CORDIS CORPORATION | 2021-01-26 |
| 10705032056090 | Biopsy Forceps | Cordis US Corp. | 2021-01-26 |
| 00817428020424 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020608 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020585 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020561 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020547 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020523 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020509 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020486 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020462 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020448 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020400 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020387 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020363 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020349 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020301 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020288 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020264 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020240 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020226 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020202 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00817428020189 | SparrowHawk | ATC TECHNOLOGIES, INC. | 2016-09-24 |
| 00886333206704 | Jawz Endomyocardial Biopsy Forceps | ARGON MEDICAL DEVICES, INC. | 2016-09-16 |
| 00886333206711 | Jawz Endomyocardial Biopsy Forceps | ARGON MEDICAL DEVICES, INC. | 2016-09-16 |