Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve
FDA 510(k) K934624 · Advanced Cardiovascular Systems, Inc.
510(k) numberK934624
Submission
- Device name
- Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- September 27, 1993
- Decision date
- April 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012534 | Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 01/24/2002SE |
| K000550 | Otw Megalink SDS Biliary Stent SystemFGE · Special | 03/17/2000SESU |
| K994229 | Veripath Peripheral Guiding CatheterDQY · Special | 02/25/2000SE |
| K992169 | Acs Hi-Torque Cross-It 400XT Guide WireDQX · Traditional | 10/28/1999SE |
| K990867 | RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1…FGE · Traditional | 09/02/1999SESU |
| 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 |
| K953987 | Acs Tourgide Guiding CatheterDQY · Traditional | 12/07/1995SE |
Questions and answers
When was Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve cleared by the FDA?
Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve (K934624) received a 510(k) decision of Substantially Equivalent on April 13, 1994, 198 days after the submission was received.
What is the product code of K934624?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.