Interlock™
Fibered IDC™ Occlusion System
6manufacturers in China registered for this device type
26catalogue numbers in this listing
16510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001361770 | 2 mm Diameter | In distribution |
| M001361740 | 2 mm Diameter | In distribution |
| M001361960 | 22 mm Diameter | In distribution |
| M001361560 | 6 mm Diameter | In distribution |
| M001361630 | 14 mm Diameter | In distribution |
| M001361620 | 12 mm Diameter | In distribution |
| M001361950 | 20 mm Diameter | In distribution |
| M001361580 | 8 mm Diameter | In distribution |
| M001361480 | 4 cm Length | In distribution |
| M001361490 | 6 cm Length | In distribution |
| M001361940 | 50 cm Length | In distribution |
| M001361550 | 15 cm Length | In distribution |
| M001361540 | 8 cm Length | In distribution |
| M001361640 | 30 cm Length | In distribution |
| M001361590 | 10 mm Diameter | In distribution |
| M001361610 | 20 cm Length | In distribution |
| M001361760 | 5 mm Diameter | In distribution |
| M001361530 | 4 mm Diameter | In distribution |
| M001361500 | 3 mm Diameter | In distribution |
| M001361600 | 10 mm Diameter | In distribution |
| M001361750 | 4.1 cm Length | In distribution |
| M001361920 | 50 cm Length | In distribution |
| M001361930 | 50 cm Length | In distribution |
| M001361510 | 12 cm Length | In distribution |
| M001361570 | 6 mm Diameter | In distribution |
| M001361520 | 8 cm Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261488 | 2026-07-24 |
| K253376 | 2025-10-30 |
| K242507 | 2024-10-03 |
| K230706 | 2023-06-27 |
| K213398 | 2022-04-12 |
| K141378 | 2014-10-08 |
| K133208 | 2013-11-14 |
| K132578 | 2013-09-13 |
| K113651 | 2012-01-11 |
| K112103 | 2011-08-12 |
| K102912 | 2011-03-03 |
| K110295 | 2011-03-03 |
| K102714 | 2011-02-11 |
| K060078 | 2006-01-31 |
| K040342 | 2004-04-13 |
| K034068 | 2004-03-26 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-02-20 | Class I | Under Investigation by firm | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequen | 985 units |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
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.