Venous Cannula Tray
FDA 510(k) K813284 · Cunningham Woodland, Inc.
510(k) numberK813284
Submission
- Device name
- Venous Cannula Tray
- Applicant
- Cunningham Woodland, Inc.
Mchenry, IL, US - Received
- November 23, 1981
- Decision date
- December 29, 1981
- 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 |
|---|---|---|
| K823527 | Subclavian Insertion KitFMF · Traditional | 03/31/1983SE |
| K813286 | Pre-Pack TENSGDY · Traditional | 01/22/1982SE |
| K813519 | Non-Absorbent TowelsKME · Traditional | 01/05/1982SE |
| K811091 | Minor Dressing TrayLDQ · Traditional | 05/08/1981SE |
| K811090 | Major Dressing TrayLDQ · Traditional | 05/08/1981SE |
| K811089 | One Step Prep KitLDQ · Traditional | 05/08/1981SE |
| K811088 | Dressing Tray Mercy HospitalLDQ · Traditional | 05/08/1981SE |
| K811087 | Mika Skin Scrub Tray Pre Operative W/GelFSM · Traditional | 05/01/1981SE |
| K811086 | Suture Removal Set(Displsable)KDD · Traditional | 05/01/1981SE |
Questions and answers
When was Venous Cannula Tray cleared by the FDA?
Venous Cannula Tray (K813284) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 36 days after the submission was received.
What is the product code of K813284?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.