Hemo-Cath®
8F X 24CM Hemo-Cath® Silicone Double Lumensilicone DO Catheter Setcatheter SET (Cuff 21CM From TIP)(Cuff 21CM F
1manufacturer
37catalogue numbers in this listing
5510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Medical Components Inc, United States |
|---|---|
| FDA product code | LFJ |
| Device type | Catheter, Subclavian |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-23 |
| Record revised | 2022-07-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Packaging | Box of 5, box of 10 |
| Distribution end date | 2026-04-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCDLTSL20 | In distribution | |
| DSL32 | In distribution | |
| MCDLTSL20 | In distribution | |
| MCDLTSL15 | In distribution | |
| DSL12 | In distribution | |
| SL12P | In distribution | |
| DSL24P | In distribution | |
| MCDLTSL15 | In distribution | |
| MCDLTSL24 | In distribution | |
| SL20CIJ | In distribution | |
| DSL27 | In distribution | |
| MCDLTSL27 | In distribution | |
| MCDLTSL24 | In distribution | |
| DSL28 | In distribution | |
| DSL12P | In distribution | |
| MCDLTSL27 | In distribution | |
| SL24C | Withdrawn | |
| DSL15IJS | Withdrawn | |
| SL24P | Withdrawn | |
| SL15CIJ | Withdrawn | |
| TRAY #373 | Withdrawn | |
| SL20 | Withdrawn | |
| SL15 | Withdrawn | |
| SL12 | Withdrawn | |
| RMS06107 | Withdrawn | |
| SL15IJS | Withdrawn | |
| SL24 | Withdrawn | |
| DSL28C | Withdrawn | |
| SL15C | Withdrawn | |
| RMS06106 | Withdrawn | |
| SL18P | Withdrawn | |
| SL27 | Withdrawn | |
| DSL32C | Withdrawn | |
| SL15IJ | Withdrawn | |
| SL20C | Withdrawn | |
| MCDLTSL24P | Withdrawn | |
| MCDLTSL18P | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 45 |
| SLX Hemo-Cath® | Medical Components Inc | 28 |
| Permcath | Mozarc Medical US LLC | 9 |
| Silicone Hemo-Cath-NO Cuff/Acutesilicone Hemo-Cath-NO Cuff/Acute | Medical Components Inc | 6 |
| Brevia Short Term Dialysis Catheter | Bard Access Systems, Inc. | 4 |
| Mahurkar | Mozarc Medical US LLC | 4 |
| Argyle | Mozarc Medical US LLC | 4 |
| Brevia Dialysis Catheter Kit | Bard Access Systems, Inc. | 4 |
| Schon | AngioDynamics, Inc. | 4 |
| Hemo-Cath® Silicone | Medical Components Inc | 3 |
| Hemo-Cath®ij | Medical Components Inc | 2 |
| Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm | Bard Access Systems, Inc. | 1 |
Showing 12 of 25. All products under Catheter, Subclavian
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K915423 | 1993-02-02 |
| K893439 | 1989-06-13 |
| K890029 | 1989-04-17 |
| K821684 | 1982-06-24 |
| K801672 | 1980-12-18 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-03-13 | Class II | Labeling Change Control | Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. | 6830 | 2024-03-05 |
| 2019-03-13 | Class II | Finished device change control | Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. | 6830 | 2024-03-05 |
| 2019-03-13 | Class II | Labeling Change Control | Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. | 6830 | 2024-03-05 |
| 2019-03-13 | Class II | Labeling Change Control | Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. | 6830 | 2024-03-05 |
| 2015-01-21 | Class II | Process control | Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled | 243 | 2015-08-03 |
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.