Optical Catheter(Tm) Introducer Sets
FDA 510(k) K895041 · Medical Dynamics, Inc.
510(k) numberK895041
Submission
- Device name
- Optical Catheter(Tm) Introducer Sets
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- August 9, 1989
- Decision date
- October 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K022306 | Aart Silicone TubingKGZ · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 10/10/2002SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | Byron Medical | 02/10/1998SE |
| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | Allied Biomedical Corp. | 01/26/1996SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | Navarre Biomedical , Ltd. | 07/08/1994SE |
| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K873009 | Concept Switching StickKGZ · Traditional | Concept, Inc. | 08/17/1987SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
| K864115 | Tubegripper, Drainage Catheter & Accessory for SuKGZ · Traditional | Cathaid, Inc. | 11/07/1986SE |
More from Cathaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974542 | True Vision, True Vision IIEIA · Traditional | 02/17/1998SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | 07/20/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | 02/15/1994SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | 07/22/1993SE |
| K915538 | Over the Wire Stone BasketLQR · Traditional | 03/20/1992SE |
| K914315 | Optical Catheter Introducer Sets, ModificationKGX · Traditional | 03/04/1992SE |
| K913986 | Cholangiography/Cholangioscopy/Lihopaxy SystemFGE · Traditional | 01/28/1992SESK |
| K911296 | Optical Catheter ArthroscopeHRX · Traditional | 09/24/1991SE |
| K903339 | Video Endoscope, RigidHET · Traditional | 03/06/1991SE |
| K904609 | Xenon Light SourceHBI · Traditional | 12/18/1990SE |
Questions and answers
When was Optical Catheter(Tm) Introducer Sets cleared by the FDA?
Optical Catheter(Tm) Introducer Sets (K895041) received a 510(k) decision of Substantially Equivalent on October 16, 1989, 68 days after the submission was received.
What is the product code of K895041?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.