Panels › General Hospital › Product code FPK · Class 2
Tubing, Fluid Delivery
Regulation 880.5440
0510(k)s in 12 months (64 all time)
0recalls in 12 months (28 all time)
18recalls that name a 510(k)
Top companies in FPK
| Company | 510(k)s | Recalls |
|---|---|---|
| MOOG Medical Devices Group | 0 | 14 |
| Mentor Texas, Inc | 0 | 9 |
| Churchill Corp. | 3 | 0 |
| Clinical Connections, Inc. | 3 | 0 |
| 3M Company | 2 | 0 |
| Degania Silicone , Ltd. | 2 | 0 |
| Distronic Sterile Products, Inc. | 2 | 0 |
| Harvard Laboratories | 2 | 0 |
| Hospira, Inc. | 1 | 1 |
| Medrad, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 1981 | K810005 | SAFEED EXTENSION TUBES Terumo Medical Corp. | FPK |
| Jun 17, 1980 | K800879 | CLEAR PLASTIC CONNECTING TUBES Harvard Laboratories | FPK |
| Jun 17, 1980 | K800877 | ANESTHESIA EXTENSION TUBES Harvard Laboratories | FPK |
| May 14, 1980 | K800825 | EXTENSION SET QUEST CODE #3000 Quest Medical, Inc. | FPK |
| Nov 22, 1978 | K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING Mcghan Medical Corp. | FPK |
| May 16, 1978 | K780673 | CENTRAL CATHETER KIT Argon Medical Corp. | FPK |
| Mar 22, 1978 | K780396 | NASAL GASTRIC TUBE RETAINER Mor-Mac, Inc. | FPK |
| Nov 14, 1977 | K772119 | TIME WATCH Akzona, Inc. | FPK |
| Sep 12, 1977 | K771269 | BLOOD COLLECTION SET TYPE H Berman, Pcp & Consultants, Inc. | FPK |
| Aug 22, 1977 | K771387 | MONITORING LINES & FLUID ADMIN. Norton Performance Plastics Corp. | FPK |
| Jun 29, 1977 | K770945 | POUCH, TYVEK-POLYMYLON Medical Disposables Intl., Inc. | FPK |
| Jun 20, 1977 | K770596 | CONNECTORS Abco Dealers, Inc. | FPK |
| Mar 30, 1977 | K770174 | LUER-LOCK EXTENSION SET American Viggo | FPK |
| Mar 10, 1977 | K770108 | TUBE HOLDING DEVICE Pharmaseal Div., Baxter Healthcare Corp. | FPK |
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