Pediasat
Pediasat Oximetry Catheter SET
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K053609 |
| Record published | 2016-09-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XT248SP | EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM) | In distribution |
| XT3515SP | EXTERIOR DIAMETER: 5.5F (1.83MM), USABLE LENGTH: 15CM, RECOMMENDED GUIDEWIRE SIZE: 0.025 IN (0.64 MM) | In distribution |
| XT245KTP | EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093554 | 2010-04-13 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 70 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 200 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 218 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 178 units | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 50 units | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 152 units | 2024-01-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.