Cath-Guide
FDA 510(k) K955645 · Hudson Respiratory Care, Inc.
510(k) numberK955645
Submission
- Device name
- Cath-Guide
- Applicant
- Hudson Respiratory Care, Inc.
Mccordsville, IN, US - Received
- December 12, 1995
- Decision date
- March 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K031383 | Model 780BTT · Special | 07/07/2003SE |
| K011134 | Oxygen Supply Tubing, Model 1115BYX · Traditional | 06/13/2001SE |
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | 06/13/2001SE |
| K010402 | Smooth-Flo CircuitBTT · Special | 03/14/2001SE |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60BTT · Traditional | 11/03/2000SE |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40…BTT · Traditional | 05/24/2000SE |
| K994352 | Side Draft Neb-U-Mist Nebulizer, Model 41896CAF · Traditional | 03/22/2000SE |
| K964719 | Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorBTM · Traditional | 02/21/1997SE |
| K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaCCK · Traditional | 09/10/1996SE |
| K961914 | Bacteria/Viral FilterCAH · Traditional | 08/14/1996SE |
Questions and answers
When was Cath-Guide cleared by the FDA?
Cath-Guide (K955645) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 91 days after the submission was received.
What is the product code of K955645?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.