AMT MiniSPC Drainage Set
The AMT MiniSPC Drainage Set connects a low-profile suprapubic urinary catheter to a separate urine collection bag. It carries fluid from the bladder through the catheter into the bag. The…
The AMT MiniSPC Drainage Set connects a low-profile suprapubic urinary catheter to a separate urine collection bag. It carries fluid from the bladder through the catheter into the bag. The set is the external drainage connection, used with the MiniSPC catheter placed through an abdominal cystostomy opening.
A right-angle connector mates with the catheter’s interlocking port. Tubing directs the drainage from that connection to the external collection system. The set works with the catheter’s low-profile external connection; the separate catheter and retention balloon provide access to the bladder and hold the catheter in position.
Listed Item
12″ Right Angle Drainage Set – For Use with the MiniSPC Button (Pouched), MDR
Use Context
The system is indicated for patients aged seven or older requiring temporary suprapubic urinary diversion and drainage for up to four weeks. It is supplied sterile for single use.
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 |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | KOB |
| Device type | Catheter, Suprapubic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K240514 |
| Record published | 2025-01-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box (s1-1221) of 10, box (s1-2421) of 10 |
| Sizes | Length 12 to 24 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES1-1221 | Length 12 in | In distribution |
| ES1-1221 | Length 12 in | In distribution |
| ES1-2421 | Length 24 in | In distribution |
| ES1-2421 | Length 24 in | In distribution |
| ES1-2421 | Length 24 in | In distribution |
| ES1-1221 | Length 12 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MiniSPC Button | Applied Medical Technology, Inc. | 284 |
| Malecot | Cook Incorporated | 39 |
| Cook | Cook Incorporated | 35 |
| Stamey | Cook Incorporated | 16 |
| Silicone Supra-Pubic Catheter (Ordinary Balloon) | Fortune Medical Instrument Corp. | 10 |
| Rutner | Cook Incorporated | 9 |
| Silicone Supra-Pubic Catheter (Integrated Balloon) | Fortune Medical Instrument Corp. | 8 |
| Cook-Cope Loop | Cook Incorporated | 8 |
| Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) | Fortune Medical Instrument Corp. | 7 |
| S-Cath™ | Mediplus Ltd. | 7 |
| Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) | Fortune Medical Instrument Corp. | 7 |
| Mediplus | Mediplus Ltd. | 6 |
Showing 12 of 23. All products under Catheter, Suprapubic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240514 | 2024-11-01 |
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.