Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial Intubation
FDA 510(k) K953963 · Rusch, Inc.
510(k) numberK953963
Submission
- Device name
- Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial Intubation
- Applicant
- Rusch, Inc.
Jeffrey, NH, US - Received
- August 22, 1995
- Decision date
- November 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTS – Tube, Bronchial (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5720
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951091 | Rusch Endobronchial Tube SetsBTS · Traditional | Rusch Intl. | 06/08/1995SE |
| K902116 | Modified Endobronchial TubeBTS · Traditional | Concord/Portex | 08/03/1990SE |
| K834565 | Endobronchial Twin Lumen TubeBTS · Traditional | Portex, Inc. | 01/17/1984SE |
| K833297 | Bronchoscopy Tube W/Ultra LocuffBTS · Traditional | Surgitek | 12/27/1983SE |
| K771219 | Broncho-CathBTS · Traditional | Mallinckrodt Critical Care | 08/04/1977SE |
More from Mallinckrodt Critical Care
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|---|---|---|
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | 05/09/2001SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | 03/24/2000SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | 06/09/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
Questions and answers
When was Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial Intubation cleared by the FDA?
Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial Intubation (K953963) received a 510(k) decision of Substantially Equivalent on November 27, 1995, 97 days after the submission was received.
What is the product code of K953963?
The FDA product code is BTS – Tube, Bronchial (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5720.