Boston Pacific Medical, Inc.
Boston, MA, US
Boston Pacific Medical, Inc. appears in FDA device records in Boston, MA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Boston Pacific Medical, Inc. between 1992 and 1994. The busiest year on record is 1993, with 5. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 5 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933109 | 4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS | KOD | Unknown | |
| K922402 | 4 SURE TM ENTERAL FEEDING BAG | FPD | Substantially Equivalent | |
| K931048 | 4-SURE NELATON CATHETER | EZD | Substantially Equivalent | |
| K931047 | 4-SURE FEMALE CATHETER | EZD | Substantially Equivalent | |
| K921852 | 4 SURE TM RECTAL TUBE | KMO | Substantially Equivalent | |
| K921853 | 4 SURE TM FEEDING TUBES | KNT | Substantially Equivalent | |
| K921851 | 4 SURE TM SUCTION CATHETERS & KITS | BSY | Unknown | |
| K922398 | 4 SURE TM ENEMA BAG SET | FCE | Unknown | |
| K922397 | 4 SURE TM NASAL OXYGEN CANNULA | CAT | Substantially Equivalent | |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | BSO | Substantially Equivalent | |
| K922401 | 4 SURE TM COLOSTOMY POUCH | EZQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain