510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BTCClass I

Bag, Reservoir

21 CFR 868.5320 / Anesthesiology
FDA source (opens on fda.gov)

BTC is the FDA product code for Bag, Reservoir, a class I device type, regulated under 21 CFR 868.5320. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
BTC
Device name
Bag, Reservoir
Regulation
21 CFR 868.5320
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
7

Clearances, product code BTC

By decision year
19 clearances under product code BTC with a decision year between 1979 and 2018, 1993 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code BTC by decision year
YearClearances
19792
19801
19823
19832
19842
19871
19881
19891
19934
19941
20181

Applicants with the most clearances

Product code BTC
Applicants holding the most 510(k) clearances under product code BTC
ApplicantClearances
Warne Surgical Products, Ltd.2
Artec Environmental Monitoring Division1
Cameron Medical Corp.1
Dryden Corp.1
Esp Plastics, Inc.1
Khi, Inc.1
King Systems Corporation.1
Life Design Systems, Inc.1
Life Shield Healthcare Products, Inc.1
Med-Plastics Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order