Acs Urethan Coronary Guiding Catheter
FDA 510(k) K904884 · Advanced Cardiovascular Systems, Inc.
510(k) numberK904884
Submission
- Device name
- Acs Urethan Coronary Guiding Catheter
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- October 26, 1990
- Decision date
- January 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K963702 | Acs Hi-Torque Iron Man Guide WireDQX · Traditional | 01/22/1997SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | 09/12/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | 05/08/1996SESK |
| K955175 | Acs Anchor Exchange DeviceDQX · Traditional | 04/05/1996SE |
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Questions and answers
When was Acs Urethan Coronary Guiding Catheter cleared by the FDA?
Acs Urethan Coronary Guiding Catheter (K904884) received a 510(k) decision of Substantially Equivalent on January 3, 1991, 69 days after the submission was received.
What is the product code of K904884?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.