Modification to Acs Coronary Guiding
FDA 510(k) K841992 · Advanced Cardiovascular Systems, Inc.
510(k) numberK841992
Submission
- Device name
- Modification to Acs Coronary Guiding
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- April 25, 1984
- Decision date
- June 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040431 | Roche Diagnostics Tina-Quant Igm GEN.2DAO · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K982639 | Spife Urine IfeDAO · Traditional | Helena Laboratories | 11/04/1998SE |
| K955908 | Boehringer Mannheim Igm AssayDAO · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | Applications Lab | 03/14/1985SE |
| K812487 | Immunogl. Frct. of Rabbit Antiser.-IgmDAO · Traditional | Dako Corp. | 09/23/1981SE |
| K800450 | Gemeni Igm AssayDAO · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/24/1980SE |
| K790705 | Antiserum to Human IgmDAO · Traditional | Kent Laboratories, Inc. | 04/12/1979SESP |
More from Kent Laboratories, 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 Modification to Acs Coronary Guiding cleared by the FDA?
Modification to Acs Coronary Guiding (K841992) received a 510(k) decision of Substantially Equivalent on June 11, 1984, 47 days after the submission was received.
What is the product code of K841992?
The FDA product code is DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.