Daig Collapsible Sterile Sleeve
FDA 510(k) K884478 · Daig Corp.
510(k) numberK884478
Submission
- Device name
- Daig Collapsible Sterile Sleeve
- Applicant
- Daig Corp.
Minnetonka, MN, US - Received
- October 25, 1988
- Decision date
- February 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
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|---|---|---|---|
| K131446 | Integra Jarit Heparin Cannulas, Injectors, and NeedlesDQR · Traditional | Integra LifeSciences Corporation | 10/28/2013SE |
| K073559 | 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special | Edwards Lifesciences Research Medical | 01/31/2008SE |
| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | AngioDynamics, Inc. | 09/12/2005SE |
| K030398 | Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional | Cardiacassist, Inc. | 05/23/2003SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | Research Medical, Inc. | 03/26/1996SE |
| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | Datascope Corp. | 01/16/1991SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | Shiley, Inc. | 03/28/1990SE |
| K894243 | Rmi Arterial Perfusion CannulaDQR · Traditional | Research Medical, Inc. | 09/19/1989SE |
| K884628 | Harborin Central Venous CatheterDQR · Traditional | Harbor Medical Devices, Inc. | 05/15/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | Argon Medical Corp. | 01/11/1989SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K000004 | Alliance Left Heart Delivery System Introducer, Model #407509DYB · Traditional | 11/29/2000SE |
| K994334 | Ultra-Flex Hemostasis Introducer. Model 406XXXDYB · Special | 05/15/2000SE |
| K982299 | Spyglass 5 FR Angiographic CatheterDQO · Traditional | 10/19/1998SE |
| K982187 | Fast-Cath Intra-Cardiac IntroducerDYB · Traditional | 09/16/1998SE |
| K973840 | Fast-Cath (TM) Intra-Cardiac IntroducerDYB · Traditional | 05/21/1998SE |
| K964518 | Fast-Cath Transseptal Catheter IntroducerDYB · Traditional | 05/14/1997SE |
| K965249 | Spyglass Angiographic CatheterDQO · Traditional | 02/21/1997SE |
| K962805 | Spyglass Angiographic CatheterDQO · Traditional | 10/15/1996SE |
| K954317 | Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/Sideports & 3-WAY StopcocksDYB · Traditional | 11/28/1995SE |
| K944284 | ControlDQO · Traditional | 03/03/1995SE |
Questions and answers
When was Daig Collapsible Sterile Sleeve cleared by the FDA?
Daig Collapsible Sterile Sleeve (K884478) received a 510(k) decision of Substantially Equivalent on February 22, 1989, 120 days after the submission was received.
What is the product code of K884478?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.