Clearview(Tm) Angioscopic Irrigation Pump
FDA 510(k) K902444 · Intramed Laboratories, Inc.
510(k) numberK902444
Submission
- Device name
- Clearview(Tm) Angioscopic Irrigation Pump
- Applicant
- Intramed Laboratories, Inc.
San Diego, CA, US - Received
- June 1, 1990
- Decision date
- August 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQI – Withdrawal/Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1800
- Specialty
- Cardiovascular
Other 510(k)s with product code DQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960486 | Ksea Model 383320 20 AngiomatDQI · Traditional | Karl Storz Endoscopy | 10/25/1996SE |
| K935763 | SurgipumpDQI · Traditional | W.O.M. World of Medicine GmbH | 04/21/1994SE |
| K922541 | Usci Super 9 Ptca Guiding CatheterDQI · Traditional | C.R. Bard, Inc. | 12/08/1992SE |
| K924110 | Leocor Corflo Pump -- ModificationDQI · Traditional | Leocor, Inc. | 09/01/1992SE |
| K905189 | Baxter Angioscopy Pump Tubing Set (Model NL)DQI · Traditional | Baxter Healthcare Corp | 01/30/1991SE |
| K895688 | Nobles-Lai Engineering Infusion PumpDQI · Traditional | Nobles-Lai Engineering, Inc. | 02/26/1990SE |
| K895074 | Angioscopy PumpDQI · Traditional | Baxter Healthcare Corp | 01/31/1990SE |
| K871422 | Olympus Angioscopy PumpDQI · Traditional | Olympus Corp. | 08/12/1987SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953258 | Titanium Hemostatic ClipFZP · Traditional | 01/05/1996SE |
| K942457 | Graft Thrombectomy InstrumentsMCW · Traditional | 02/07/1995SE |
| K931792 | ArthroscopeHRH · Traditional | 06/13/1994SE |
| K925283 | ValvulotomeMGZ · Traditional | 02/10/1994SE |
| K934696 | AngioscopeLYK · Traditional | 01/18/1994SE |
| K922114 | Endoscopic Retrieval BasketFFL · Traditional | 08/03/1992SE |
| K914385 | Optical ValvulotomeMGZ · Traditional | 03/02/1992SE |
| K904465 | Flexible ArthroscopeHRX · Traditional | 12/20/1990SE |
| K903528 | LaparoscopeHET · Traditional | 09/04/1990SE |
| K901010 | Flexible CholedochoscopeFBN · Traditional | 05/22/1990SE |
Questions and answers
When was Clearview(Tm) Angioscopic Irrigation Pump cleared by the FDA?
Clearview(Tm) Angioscopic Irrigation Pump (K902444) received a 510(k) decision of Substantially Equivalent on August 30, 1990, 90 days after the submission was received.
What is the product code of K902444?
The FDA product code is DQI – Withdrawal/Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 870.1800.