Lab-Site Safety Needle
FDA 510(k) K905018 · Telos Medical Corp.
510(k) numberK905018
Submission
- Device name
- Lab-Site Safety Needle
- Applicant
- Telos Medical Corp.
Keene, CA, US - Received
- November 7, 1990
- Decision date
- January 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K920375 | Disposable Intrauterine Pressure TransducerHFN · Traditional | 10/27/1992SE |
| K920044 | Dual Lumen Transcerivical Intrauterine KitKXO · Traditional | 04/03/1992SE |
| K914387 | Transcervical Intrauterine KitHGS · Traditional | 12/30/1991SE |
| K905017 | Lab-SiteDQO · Traditional | 01/15/1991SE |
| K882224 | Ultrans Disposable IntrauterineHFN · Traditional | 10/12/1989SE |
| K883832 | Catheter, Intrauterine and IntroducerKXO · Traditional | 12/13/1988SE |
Questions and answers
When was Lab-Site Safety Needle cleared by the FDA?
Lab-Site Safety Needle (K905018) received a 510(k) decision of Substantially Equivalent on January 16, 1991, 70 days after the submission was received.
What is the product code of K905018?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.