Straight Adapt W/Temp Sensing Port/Closure Plug
FDA 510(k) K861056 · Intertech/Ohio
510(k) numberK861056
Submission
- Device name
- Straight Adapt W/Temp Sensing Port/Closure Plug
- Applicant
- Intertech/Ohio
Fort Myers, FL, US - Received
- March 19, 1986
- Decision date
- March 27, 1986
- 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 |
|---|---|---|
| K895144 | Intertech Metered Dose ElbowBZA · Traditional | 10/19/1989SE |
| K890346 | Intertech Universal Hydrophobic FilterCAH · Traditional | 03/01/1989SE |
| K884525 | Pediatric Humidifier Tube W/ Temperature PortBZO · Traditional | 12/16/1988SE |
| K884526 | Adult Resuscitator with Mask and FilterBTM · Traditional | 11/16/1988SE |
| K882204 | Resuscitator Valve Assembly W/FilterCBP · Traditional | 07/08/1988SE |
| K880394 | First Response Pediatric Emergency ResuscitatorBTM · Traditional | 02/29/1988SE |
| K863033 | Patient Gas Sampling KIT/5STAND Alone VersionsBZO · Traditional | 08/20/1986SE |
| K862020 | Heat/Moisture Exchanger, Hme, W/Integral FilterBYD · Traditional | 06/30/1986SE |
| K860650 | 90 Degree Elbow & Straight ConnectorBZA · Traditional | 03/28/1986SE |
Questions and answers
When was Straight Adapt W/Temp Sensing Port/Closure Plug cleared by the FDA?
Straight Adapt W/Temp Sensing Port/Closure Plug (K861056) received a 510(k) decision of Substantially Equivalent on March 27, 1986, 8 days after the submission was received.
What is the product code of K861056?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.