Pma Angiography Tray
FDA 510(k) K841468 · Professional Medical Services
510(k) numberK841468
Submission
- Device name
- Pma Angiography Tray
- Applicant
- Professional Medical Services
Mchenry, IL, US - Received
- April 9, 1984
- Decision date
- June 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
Other 510(k)s with product code DWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913094 | Disposable Slide Valve ManifoldDQO · Traditional | 01/27/1992SE |
| K910378 | Pressure Monitoring Extension LineDQO · Traditional | 04/22/1991SE |
| K904508 | Condor Analog Inflation SyringeMAV · Traditional | 04/02/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | 01/16/1991SE |
| K902606 | Radiopaque RulerKPR · Traditional | 09/27/1990SE |
| K884577 | Procedure Ready TraysFOZ · Traditional | 08/01/1989SESD |
| K890471 | PMS Angio DrapeKKX · Traditional | 02/27/1989SE |
| K884497 | Control SyringeFMF · Traditional | 12/12/1988SE |
| K872448 | Blood Containment PackLRO · Traditional | 11/17/1987SE |
| K864555 | 3 Ring AttachmentFMF · Traditional | 12/01/1986SE |
Questions and answers
When was Pma Angiography Tray cleared by the FDA?
Pma Angiography Tray (K841468) received a 510(k) decision of Substantially Equivalent on June 5, 1984, 57 days after the submission was received.
What is the product code of K841468?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.