Reusable Mlyocardial Biopsy Forceps (Bioptomes
FDA 510(k) K890453 · Dlp, Inc.
510(k) numberK890453
Submission
- Device name
- Reusable Mlyocardial Biopsy Forceps (Bioptomes
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- January 30, 1989
- Decision date
- March 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWZ – Device, Biopsy, Endomyocardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4075
- Specialty
- Cardiovascular
Other 510(k)s with product code DWZ
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|---|---|---|---|
| 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 |
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| K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer…DWF · Traditional | 03/26/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | 01/09/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
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Questions and answers
When was Reusable Mlyocardial Biopsy Forceps (Bioptomes cleared by the FDA?
Reusable Mlyocardial Biopsy Forceps (Bioptomes (K890453) received a 510(k) decision of Substantially Equivalent on March 31, 1989, 60 days after the submission was received.
What is the product code of K890453?
The FDA product code is DWZ – Device, Biopsy, Endomyocardial, a Class II (moderate risk) device regulated under 21 CFR 870.4075.