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FDA 510(k)

BRONCHITRAC DF DUAL RESP/CATHETER

K-Number: K833633 · 1983-12-08

ApplicantAckrad Laboratories
Decision Date1983-12-08
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRONCHITRAC DF DUAL RESP/CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833633. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRONCHITRAC DF DUAL RESP/CATHETER?

BRONCHITRAC DF DUAL RESP/CATHETER is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Ackrad Laboratories. The 510(k) number is K833633.

When did BRONCHITRAC DF DUAL RESP/CATHETER receive FDA 510(k) clearance?

BRONCHITRAC DF DUAL RESP/CATHETER received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833633.

Who is the listed applicant for BRONCHITRAC DF DUAL RESP/CATHETER?

The FDA 510(k) record lists Ackrad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRONCHITRAC DF DUAL RESP/CATHETER?

The FDA product code for BRONCHITRAC DF DUAL RESP/CATHETER is BSY.

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Other records listing Ackrad Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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Related Devices (Code: BSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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