Cardioxyl ®
162 catalogue numbers from 73I10C, listed by Peters Surgical, France, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
162catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Peters Surgical, France |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K060163 |
| Record published | 2020-01-09 |
| Record revised | 2026-04-13 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12, pack of 36, pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 73I10C | In distribution | |
| 73S30AQ | In distribution | |
| 73S30Y | In distribution | |
| 73S30AT | In distribution | |
| 73P30S | In distribution | |
| 73S10M | In distribution | |
| 73S30M | In distribution | |
| 73S30CB | In distribution | |
| 73P20J | In distribution | |
| 73P20G | In distribution | |
| 73P30CR | In distribution | |
| 73P10A | In distribution | |
| 73S30Q | In distribution | |
| 73P30I | In distribution | |
| 73P30G | In distribution | |
| 73P30B | In distribution | |
| 73S30U | In distribution | |
| 73I30AB | In distribution | |
| 73P30DY | In distribution | |
| 73I30AP | In distribution | |
| 73S20J | In distribution | |
| 73S15G | In distribution | |
| 73P30BC | In distribution | |
| 73P30BK | In distribution | |
| 73S10G | In distribution | |
| 73I30A | In distribution | |
| 73P30BU | In distribution | |
| 73S20D | In distribution | |
| 73P30K | In distribution | |
| 73P30BY | In distribution | |
| 73S20F | In distribution | |
| 73P30BS | In distribution | |
| 73P30BR | In distribution | |
| 73I30AY | In distribution | |
| 73P30F | In distribution | |
| 73S30AB | In distribution | |
| 73S30N | In distribution | |
| 73P30CF | In distribution | |
| 73P10L | In distribution | |
| 73I30R | In distribution | |
| 73R15A | In distribution | |
| 73P20R | In distribution | |
| 73S15I | In distribution | |
| 73S30T | In distribution | |
| 73P30T | In distribution | |
| 73P35A | In distribution | |
| 73I30T | In distribution | |
| 73P30AM | In distribution | |
| 73S30AZ | In distribution | |
| 73P35Q | In distribution | |
| 73S30AG | In distribution | |
| 73P10K | In distribution | |
| 73P20V | In distribution | |
| 73P10B | In distribution | |
| 73I30AN | In distribution | |
| 73P30BQ | In distribution | |
| 73S30AP | In distribution | |
| 73S30AN | In distribution | |
| 73S10J | In distribution | |
| 73P20L | In distribution | |
| 73S30A | In distribution | |
| 73P30Y | In distribution | |
| 73P30CG | In distribution | |
| 73S30W | In distribution | |
| 73S15R | In distribution | |
| 73S20M | In distribution | |
| 73P30P | In distribution | |
| 73P07B | In distribution | |
| 73R30A | In distribution | |
| 73S30AF | In distribution | |
| 73P30BJ | In distribution | |
| 73P30D | In distribution | |
| 73P07C | In distribution | |
| 73P30AT | In distribution | |
| 73P15B | In distribution | |
| 73P30CM | In distribution | |
| 73S30O | In distribution | |
| 73P30BH | In distribution | |
| 73P35D | In distribution | |
| 73S15B | In distribution | |
| 73P30BX | In distribution | |
| 73P30BT | In distribution | |
| 73S30AY | In distribution | |
| 73P30L | In distribution | |
| 73S30C | In distribution | |
| 73S30BA | In distribution | |
| 73S20B | In distribution | |
| 73P30BG | In distribution | |
| 73P30DR | In distribution | |
| 73S30X | In distribution | |
| 73P30Z | In distribution | |
| 73S15H | In distribution | |
| 73S35A | In distribution | |
| 73P30AN | In distribution | |
| 73P30AI | In distribution | |
| 73P30V | In distribution | |
| 73P30AG | In distribution | |
| 73P30BW | In distribution | |
| 73S30V | In distribution | |
| 73I30BA | In distribution | |
| 73I30AX | In distribution | |
| 73S30EA | In distribution | |
| 73P30EF | In distribution | |
| 73S10H | In distribution | |
| 73S30AR | In distribution | |
| 73S20Y | In distribution | |
| 73S20E | In distribution | |
| 73P30BF | In distribution | |
| 73S10C | In distribution | |
| 73S30AE | In distribution | |
| 73S30AA | In distribution | |
| 73P30BI | In distribution | |
| 73P30CL | In distribution | |
| 73S30AH | In distribution | |
| 73S30P | In distribution | |
| 73S30AX | In distribution | |
| 73P30DX | In distribution | |
| 73P30DK | In distribution | |
| 73P20B | In distribution | |
| 73P30AH | In distribution | |
| 73S30R | In distribution | |
| 73P30J | In distribution | |
| 73P30DS | In distribution | |
| 73P30AA | In distribution | |
| 73S20A | In distribution | |
| 73S15C | In distribution | |
| 73P20H | In distribution | |
| 73P30CA | In distribution | |
| 73P30E | In distribution | |
| 73P30BV | In distribution | |
| 73S20G | In distribution | |
| 73S20I | In distribution | |
| 73I30AZ | In distribution | |
| 73P35E | In distribution | |
| 73S15P | In distribution | |
| 73S30B | In distribution | |
| 73S15F | In distribution | |
| 73P30DV | In distribution | |
| 73P20K | In distribution | |
| 73R20A | In distribution | |
| 73P30O | In distribution | |
| 73S15N | In distribution | |
| 73S10F | In distribution | |
| 73S15Q | In distribution | |
| 73P30CK | In distribution | |
| 73I30AQ | In distribution | |
| 73R10A | In distribution | |
| 73PK30EG | In distribution | |
| 73S15K | In distribution | |
| 73P35C | In distribution | |
| 73P07A | In distribution | |
| 73P30CN | In distribution | |
| 73P30X | In distribution | |
| 73S20K | In distribution | |
| 73R35A | In distribution | |
| 73P30Q | In distribution | |
| 73P30R | In distribution | |
| 73P30CP | In distribution | |
| 73P30U | In distribution | |
| 73P30DW | In distribution | |
| 73I30V | In distribution | |
| 73P30A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Silkam | B Braun Surgical SA | 150 |
| HyperSuture | Threadstone LLC | 137 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060163 | 2006-10-11 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Peters Surgical | 510(k) number | 2014-06-25 | Class II | Process control | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. | 4,976 units | 2017-12-13 |
| Peters Surgical | 510(k) number | 2014-06-25 | Class II | Process control | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. | 22,190 units | 2017-12-13 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.