Tubegripper, Drainage Catheter & Accessory for Su
FDA 510(k) K864115 · Cathaid, Inc.
510(k) numberK864115
Submission
- Device name
- Tubegripper, Drainage Catheter & Accessory for Su
- Applicant
- Cathaid, Inc.
Miami, FL, US - Received
- October 10, 1986
- Decision date
- November 7, 1986
- 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
Other 510(k)s with product code KGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| 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 |
More from Health Care Innovations, Inc.
Questions and answers
When was Tubegripper, Drainage Catheter & Accessory for Su cleared by the FDA?
Tubegripper, Drainage Catheter & Accessory for Su (K864115) received a 510(k) decision of Substantially Equivalent on November 7, 1986, 28 days after the submission was received.
What is the product code of K864115?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.