4 Sure TM Nasal Oxygen Cannula
FDA 510(k) K922397 · Boston Pacific Medical, Inc.
510(k) numberK922397
Submission
- Device name
- 4 Sure TM Nasal Oxygen Cannula
- Applicant
- Boston Pacific Medical, Inc.
Boston, MA, US - Received
- May 21, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAT – Cannula, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5340
- Specialty
- Anesthesiology
Other 510(k)s with product code CAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | Hudson Respiratory Care, Inc. | 06/13/2001SE |
| K935533 | Nasal CannulaCAT · Traditional | Puritas Health Care, Inc. | 02/03/1994SE |
| K921496 | Skin Saver(Tm) Tubing Holder, Model 1921 ModifiedCAT · Traditional | Alpine Specialties, Inc. | 08/14/1992SE |
| K920573 | Cannula Nasal OxygenCAT · Traditional | B & F Medical Products, Inc. | 08/11/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | Specialty Packaging Producs, Inc. | 10/18/1991SE |
| K912197 | Skin Saver(Tm) Tubing Holder, Model 467CAT · Traditional | Alpine Specialties, Inc. | 08/20/1991SE |
| K911740 | Salter Labs Neonatal Nasal Oxygen CannulaCAT · Traditional | Salter Labs | 07/24/1991SE |
| K902420 | Catheter, Nasal, OxygenCAT · Traditional | Gainor Medical Europe, Ltd. | 04/17/1991SE |
| K896036 | The Comfortable CannulaCAT · Traditional | Comfortable Concepts Corp. | 11/17/1989SE |
| K892435 | Kendall Curity Oxygen Nasal CannulaCAT · Traditional | The Kendal Co. | 06/12/1989SE |
More from The Kendal Co.
| 510(k) | Device | Decision |
|---|---|---|
| K933109 | 4SURE Uro-Link Urological Procedure TraysKOD · Traditional | 03/28/1994SEKD |
| K922402 | 4 Sure TM Enteral Feeding BagFPD · Traditional | 03/25/1994SE |
| K931048 | 4-SURE Nelaton CatheterEZD · Traditional | 02/14/1994SE |
| K931047 | 4-SURE Female CatheterEZD · Traditional | 02/14/1994SE |
| K921852 | 4 Sure TM Rectal TubeKMO · Traditional | 10/08/1993SE |
| K921853 | 4 Sure TM Feeding TubesKNT · Traditional | 07/13/1993SE |
| K921851 | 4 Sure TM Suction Catheters & KitsBSY · Traditional | 07/07/1993SESK |
| K922398 | 4 Sure TM Enema Bag SetFCE · Traditional | 06/17/1993SEKD |
| K924995 | 4 Sure TM Anesthesia Extension SetBSO · Traditional | 12/30/1992SE |
| K922401 | 4 Sure TM Colostomy PouchEZQ · Traditional | 06/10/1992SE |
Questions and answers
When was 4 Sure TM Nasal Oxygen Cannula cleared by the FDA?
4 Sure TM Nasal Oxygen Cannula (K922397) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 301 days after the submission was received.
What is the product code of K922397?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.