Ultraset Catheter
FDA 510(k) K911294 · Dhd Diemolding Healthcare Div.
510(k) numberK911294
Submission
- Device name
- Ultraset Catheter
- Applicant
- Dhd Diemolding Healthcare Div.
Canastota, NY, US - Received
- March 25, 1991
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZA – Connector, Airway (Extension)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5810
- Specialty
- Anesthesiology
Other 510(k)s with product code BZA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | Polamedco, Inc. | 12/22/1995SE |
| K954197 | Disposable Flex TubeBZA · Traditional | Engstrom Medical | 10/26/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952824 | Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional | Intertex Medical, Inc. | 07/20/1995SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | Catheter Research, Inc. | 04/14/1995SE |
| K944532 | Prima, Inc. Ventilator HosesBZA · Traditional | Prima, Inc. | 12/02/1994SE |
| K944535 | Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K944534 | Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K942392 | Airway Connector with Flex TubeBZA · Traditional | Mallinckrodt Medical | 08/22/1994SE |
More from Mallinckrodt Medical
| 510(k) | Device | Decision |
|---|---|---|
| K973532 | Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral ActuatorCAF · Traditional | 03/19/1998SE |
| K970596 | DHD Emerald ProductBWF · Traditional | 05/16/1997SE |
| K961973 | DHD Ace with Mask KitCAF · Traditional | 08/15/1996SE |
| K953206 | DHD Metered Dose Inhaler (Mdi) Spacer (Modification)CAF · Traditional | 08/28/1995SE |
| K945118 | Expiratory Breathing ExerciserBWF · Traditional | 01/13/1995SE |
| K944900 | TherapepBWF · Traditional | 01/06/1995SE |
| K926301 | Ace Aerosol Enhancer, Hand Held Oral Inhalation CoCAF · Traditional | 07/21/1993SE |
| K922537 | DuralifeBZA · Traditional | 12/04/1992SE |
| K913726 | Duralife(Tm)BZA · Traditional | 02/07/1992SE |
| K913326 | DHD Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 01/07/1992SE |
Questions and answers
When was Ultraset Catheter cleared by the FDA?
Ultraset Catheter (K911294) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 77 days after the submission was received.
What is the product code of K911294?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.