Namic Seldinger Introducer Needle
FDA 510(k) K871378 · North American Instrument Corp.
510(k) numberK871378
Submission
- Device name
- Namic Seldinger Introducer Needle
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- April 7, 1987
- Decision date
- May 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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More from Synaptic Medical Limited
| 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 Namic Seldinger Introducer Needle cleared by the FDA?
Namic Seldinger Introducer Needle (K871378) received a 510(k) decision of Substantially Equivalent on May 6, 1987, 29 days after the submission was received.
What is the product code of K871378?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.