PerClot
PerClot 38cm Laparoscopic Tip
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Huan QIU LI Kang Biotech Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | LMG |
| Device type | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Device class | Class 3 |
| Regulation | 21 CFR 878.4490 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | P210036 |
| Record published | 2023-06-23 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PCET038 | In distribution | ||
| PCUS003 | In distribution | ||
| PCET020 | 2 | In distribution | |
| PCUS005 | In distribution | ||
| PCUS001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgicel | Ethicon Sàrl | 8 |
| Surgicel NU-Knit | Ethicon Sàrl | 6 |
| Surgicel SNoW | Ethicon, Inc. | 6 |
| Arista | Davol Inc. | 6 |
| Surgicel Fibrillar | Ethicon, Inc. | 5 |
| Emergency Medical Products | Emergency Medical Products, Inc. | 3 |
| Veriset | Covidien LP | 3 |
| Surgicel Fibrillar | Ethicon Sàrl | 3 |
| Surgicel | Ethicon, Inc. | 1 |
| Tabotamp Fibrillar | Ethicon, Inc. | 1 |
| Ethicon | Ethicon, Inc. | 1 |
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 |
|---|---|---|---|
| P210036 | 2023-05-19 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation |
| N12159 | 2023-04-04 | SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) | Ethicon, Inc. |
| P050038 | 2012-03-23 | ARISTA AH ABSORBABLE HEMOSTAT | Davol Inc. |
| N5798 | 1991-02-08 | OXYCELL | 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.