Model TA-CS10 Spectraject Control Syringe
FDA 510(k) K880740 · Spectramed, Inc.
510(k) numberK880740
Submission
- Device name
- Model TA-CS10 Spectraject Control Syringe
- Applicant
- Spectramed, Inc.
Oxnard, CA, US - Received
- February 24, 1988
- Decision date
- March 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQF – Actuator, Syringe, Injector Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1670
- Specialty
- Cardiovascular
Other 510(k)s with product code DQF
More from Alcon Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K896122 | Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. TippedKXO · Traditional | 01/19/1990SE |
| K892941 | Cco System Model SP1467,SP5567,SP6267KRB · Traditional | 11/06/1989SE |
| K895323 | Model Dt-Bal, Balance SaverKXO · Traditional | 10/24/1989SE |
| K894362 | Model DT-IUPC2 Transducer Tipped Dual Lumen IupKXO · Traditional | 08/15/1989SE |
| K881857 | Amnicath(Tm) Model Dt-Iupc Trans. Tipped Intrau.KXO · Traditional | 02/01/1989SE |
| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | 01/25/1989SE |
| K881825 | Models SP5825/SP5835/SP5845/SP5855 Percu. SheathDYB · Traditional | 09/28/1988SE |
| K875337 | Heparin Coated Luminal Pacing CatheterDQO · Traditional | 05/25/1988SE |
| K873168 | Spectramed Disposable Transducer (Dt-Xxo) & AccessDRS · Traditional | 01/12/1988SE |
| K871573 | Central Venous Multi-Lumen Catheters and KitsDQY · Traditional | 09/16/1987SE |
Questions and answers
When was Model TA-CS10 Spectraject Control Syringe cleared by the FDA?
Model TA-CS10 Spectraject Control Syringe (K880740) received a 510(k) decision of Substantially Equivalent on March 22, 1988, 27 days after the submission was received.
What is the product code of K880740?
The FDA product code is DQF – Actuator, Syringe, Injector Type, a Class II (moderate risk) device regulated under 21 CFR 870.1670.