Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride Solution
FDA 510(k) K952396 · Contour Fabricators of Florida, Inc.
510(k) numberK952396
Submission
- Device name
- Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride Solution
- Applicant
- Contour Fabricators of Florida, Inc.
St. Petersburg, FL, US - Received
- May 22, 1995
- Decision date
- August 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSY – Catheters, Suction, Tracheobronchial
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6810
- Specialty
- Anesthesiology
Other 510(k)s with product code BSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031997 | Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional | Mallinckrodt Dar S.R.L. | 11/25/2003SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | Ambu, Inc. | 10/25/1999SE |
| K982945 | Dual Purpose Closed CatheterBSY · Traditional | Spirit Medical Systems, Inc. | 09/22/1998SE |
| K981910 | Suction CatheterBSY · Traditional | Ni-Med, Inc. | 08/24/1998SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | Mallinckrodt Medical | 12/29/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | Amsino Intl., Inc. | 09/10/1997SE |
| K961707 | Trach-Eze Closed Ventilation Suction SystemBSY · Traditional | Sorenson Critical Care | 03/11/1997SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | Ballard Medical Products | 02/11/1997SE |
| K960488 | Neo 2 Line Suction SystemBSY · Traditional | Alcove Medical, Inc. | 04/26/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | Sherwood Medical Co. | 03/28/1996SE |
More from Sherwood Medical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | 10/04/1996SE |
| K962040 | RNS Arthrogram TrayFMI · Traditional | 06/25/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | 06/03/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | 05/15/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | 05/02/1996SESK |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | 03/12/1996SE |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | 02/21/1996SE |
| K955686 | RNS, Sterile Disposable Percutaneous Cholangiographic TrayFRG · Traditional | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | 02/21/1996SE |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | 02/01/1996SE |
Questions and answers
When was Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride Solution cleared by the FDA?
Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride Solution (K952396) received a 510(k) decision of Substantially Equivalent on August 15, 1995, 85 days after the submission was received.
What is the product code of K952396?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.