Busse Plastic Tubing Connectors and Accessories
FDA 510(k) K935835 · Busse Hospital Disposables, Inc.
510(k) numberK935835
Submission
- Device name
- Busse Plastic Tubing Connectors and Accessories
- Applicant
- Busse Hospital Disposables, Inc.
Hauppauge, NY, US - Received
- December 7, 1993
- Decision date
- January 12, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYX – Tubing, Pressure And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5860
- Specialty
- Anesthesiology
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| K913422 | Oxygen Tubing, 81503BYX · Traditional | Specialty Packaging Producs, Inc. | 01/30/1992SE |
| K914980 | Hex, Quad, or Rail Block Manifold AccessoriesBYX · Traditional | Medical Fittings, Inc. | 01/21/1992SE |
| K912763 | Ohmeda Style Check Units (Female Couplers)BYX · Traditional | Medical Fittings, Inc. | 10/15/1991SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | 06/26/2012SE |
| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | 06/08/2011SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K063018 | Glass Loss of Resistance SyringeCAZ · Traditional | 01/22/2007SE |
Questions and answers
When was Busse Plastic Tubing Connectors and Accessories cleared by the FDA?
Busse Plastic Tubing Connectors and Accessories (K935835) received a 510(k) decision of Substantially Equivalent on January 12, 1994, 36 days after the submission was received.
What is the product code of K935835?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.