Palestrant Irrigation and Drainage Set
FDA 510(k) K896087 · North American Instrument Corp.
510(k) numberK896087
Submission
- Device name
- Palestrant Irrigation and Drainage Set
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- October 19, 1989
- Decision date
- November 3, 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
Other 510(k)s with product code KGZ
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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 |
| 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 |
| K864115 | Tubegripper, Drainage Catheter & Accessory for SuKGZ · Traditional | Cathaid, Inc. | 11/07/1986SE |
More from Cathaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960801 | Selector Angiographic Catheter (Various Models)DQO · Traditional | 03/29/1996SE |
| K955554 | Hemo-ValveDTL · Traditional | 03/04/1996SE |
| K960310 | Epic Introducer SheathDYB · Traditional | 02/07/1996SE |
| K922552 | Morse(R) Angiographic CathetersDQO · Traditional | 03/03/1993SE |
| K915078 | Morse Hemostatic Catheter Introducer SetDYB · Traditional | 06/10/1992SE |
| K905208 | Morse AnesthesiaFPA · Traditional | 01/10/1992SE |
| K912961 | Morse Vascular Introducer SetDYB · Traditional | 09/11/1991SE |
| K910764 | The Perceptor(Tm) Stand Alone TransducerDRS · Traditional | 04/22/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | 03/26/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | 01/03/1991SE |
Questions and answers
When was Palestrant Irrigation and Drainage Set cleared by the FDA?
Palestrant Irrigation and Drainage Set (K896087) received a 510(k) decision of Substantially Equivalent on November 3, 1989, 15 days after the submission was received.
What is the product code of K896087?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.