Sureloc Circuit Connector
FDA 510(k) K954383 · Polamedco, Inc.
510(k) numberK954383
Submission
- Device name
- Sureloc Circuit Connector
- Applicant
- Polamedco, Inc.
Marina Del Rey, CA, US - Received
- September 19, 1995
- Decision date
- December 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZA – Connector, Airway (Extension)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5810
- Specialty
- Anesthesiology
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|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| 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 |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | Thayer Medical Corp. | 08/18/1994SE |
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| K950713 | Airguide StyletteBSR · Traditional | 05/17/1995SE |
| K933596 | Gastric, Catheter, Irrigation & AspirationBSS · Traditional | 02/13/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | 02/10/1995SE |
| K920900 | Polamedco Tracheal and Nasotracheal TubesBTR · Traditional | 03/18/1992SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | 04/19/1990SE |
| K900457 | Cuffed Linder Nasotracheal AirwayBTR · Traditional | 04/16/1990SE |
| K894516 | Visoshield(Tm), Surgical Eye ProtectorFXX · Traditional | 09/12/1989SE |
| K881496 | Linder Nasotracheal AirwayBTR · Traditional | 05/31/1988SE |
Questions and answers
When was Sureloc Circuit Connector cleared by the FDA?
Sureloc Circuit Connector (K954383) received a 510(k) decision of Substantially Equivalent on December 22, 1995, 94 days after the submission was received.
What is the product code of K954383?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.