Intravenous Catheters Modifications
FDA 510(k) K921295 · Critikon Company, LLC
510(k) numberK921295
Submission
- Device name
- Intravenous Catheters Modifications
- Applicant
- Critikon Company, LLC
Tampa, FL, US - Received
- March 12, 1992
- Decision date
- May 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGO – Dislodger, Stone, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001563 | Scipro(Tm) Flexible Stone Dislodger and Retrieval SetFGO · Traditional | Scion Cardiovascular, Inc. | 11/22/2000SE |
| K970121 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 04/02/1997SE |
| K963750 | Retrieval SnareFGO · Traditional | Boston Scientific Corp | 11/22/1996SE |
| K962676 | Disposable Endoscopic Retrieval DeviceFGO · Traditional | United States Endoscopy Group, Inc. | 10/04/1996SE |
| K951309 | Stone Dislodger, BasketFGO · Traditional | Boston Scientific Corp | 05/17/1995SE |
| K933261 | Grasping ForcepsFGO · Traditional | Surgitek | 01/11/1994SE |
| K934598 | Grasping Forceps or Retrieval ForcepsFGO · Traditional | Annex Medical, Inc. | 01/07/1994SE |
| K922542 | Grasping ForcepsFGO · Traditional | Surgitek | 08/19/1992SE |
| K914112 | Metal Ureteral Basket Stone Dislodger, Flat WireFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
| K914111 | Metal Ureteral Basket Stone Dislodger, HelicalFGO · Traditional | Annex Medical, Inc. | 02/28/1992SE |
More from Annex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | 08/14/1998SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K912188 | Dinamap Plus Physiological Monitor Model 8700MHX · Traditional | 12/04/1991SE |
Questions and answers
When was Intravenous Catheters Modifications cleared by the FDA?
Intravenous Catheters Modifications (K921295) received a 510(k) decision of Substantially Equivalent on May 17, 1993, 431 days after the submission was received.
What is the product code of K921295?
The FDA product code is FGO – Dislodger, Stone, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.4680.